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Lower risk Medical device recall · FDA · Published March 25, 2021

Zav: 10G Bone Access Kit May Not Be Sterile - Recall

Zavation recalls 10G DIRECT DOUBLE BONE ACCESS KIT for orthopedic/spinal procedures due to potential inadequate sterilization. Affected items may pose infection risks.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1738-2021Medical deviceZavation ›
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Recalling firmZavation220 Lakeland Pkwy · Flowood, MS 39232-9552
✎ GovInfoNow plain-language explainer

Zavation is recalling 10G DIRECT DOUBLE BONE ACCESS KIT surgical kits used in orthopedic and spinal procedures because some may not have been properly sterilized. This could lead to infection risks for patients during surgery. Read more at govinfonow.com/recall/62908-zav-10g-bone-access-kit-may-not-be-sterile-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/62908-zav-10g-bone-access-kit-may-not-be-sterile-recall · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1738-2021

Cite this page

“Zav: 10G Bone Access Kit May Not Be Sterile - Recall.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62908-zav-10g-bone-access-kit-may-not-be-sterile-recall. Based on FDA recall #Z-1738-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1738-2021%22&limit=1).

Zavation voluntarily recalled its 10G DIRECT DOUBLE BONE ACCESS KIT on March 25, 2021, according to the FDA. The agency announced the Class II recall because products distributed as sterile may not have been adequately sterilized.

How to tell if you have it

  • Brand: Zavation
  • Product: 10G DIRECT DOUBLE BONE ACCESS KIT

The hazard

The FDA stated that the 10G DIRECT DOUBLE BONE ACCESS Kit, intended for orthopedic and spinal procedures, may not have been adequately sterilized despite being distributed as sterile.

Context

GovInfoNow's records show other recent recalls of similar products include Medline Centurion Circumcision Kit Not Sterile (2026-03-16), Medline Convenience Kits Recall regarding sterility risk from calibration issues (2026-01-07), and Medline Convenience Kits Recall for risk of contaminated sterile products (2026-01-07).

How to tell if you have this one

Check for the product name '10G DIRECT DOUBLE BONE ACCESS KIT' used in orthopedic or spinal procedures. The recall is pending, so no specific model numbers or dates are listed.

  • Brand
    Zavation
  • Category
    Medical device
FDA recall event · 71 products

All 71 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    US nationwide distribution.
Recall numberProduct, codes & lotsQuantity
Z-1700-202110 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), INTVM-DSSKBD. For use in Orthopedic / spinal procedures.; Product Batch: 19102741, 200127, 200124656 units
Z-1701-202110 GAUGE CEMENT DELIVERY CANNULA, INTVM-CDC. For use in Orthopedic / spinal procedures.; product batch: 19112827, 2002440130 units
Z-1702-2021ZVplasty Drill, 10 Gauge, REF VCF-1006. For use in Orthopedic / spinal procedures.; Product batch: 1911303638 units
Z-1703-2021ZVplasty Direct Access Beveled Tip Trocar, 10 Gauge, REF VCF-1022. For use in Orthopedic / spinal procedures.; Lot: 20071558, 19113038, 20102491, 20041108335 units
Z-1704-2021ZVplasty Direct Access Diamond Tip Trocar, 10 Gauge, REF VCF-1023. For use in Orthopedic / spinal procedures.; lot: 2004989, 1911303988 units
Z-1705-2021ZVplasty, Bipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCF-DCDK. For use in Orthopedic / spinal procedures.; lot: 2008188514 units
Z-1706-2021ZVplasty Direct Bipedicular Bone Access Kit with Drill, 10 Gauge, VCF-DDBAK. For use in Orthopedic / spinal procedures.; lot: 20071860, 2004988, 19113040, 20071775—
Z-1707-2021ZVplasty, Direct Bipedicular, Bone Access Kit with Coxaial Cannula, REF VCF-DDSKbd. For use in Orthopedic / spinal procedures.; Lot: 19113043, 200411072 units
Z-1708-2021ZVplasty Direct Unipedicular Bone Access Kit with Drill, 10 Gauge, REF VCF-DSBAK. For use in Orthopedic / spinal procedures.; lot: 19113041, 20071853, 20071714, 200380311 units
Z-1709-2021ZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCG-SCDK. For use in Orthopedic / spinal procedures.; Lot: 2003661, 19113051, 20071709, 2007184372 units
Z-1710-2021ZVplasty Bipedicular Cement Delivery Cannula, 11 Gauge, REF VCF-DCDK-11. For use in Orthopedic / spinal procedures.; Lot: 191231741 unit
Z-1711-2021ZVplasty Direct Access Bevel Tip Trocar, 11 Gauge, REF VCF-1022-11. For use in Orthopedic / spinal procedures.; Lot: 19123263, 20061381, 2007177198 units
Z-1712-2021ZVplasty Direct Access Diamond Tip Trocar, 11 Gauge, REF VCF-1023-11. For use in Orthopedic / spinal procedures.; Lot: 19123264, 20071773113 units
Z-1713-2021ZVplasty Direct Bipedicular Bone Access Kit with Drill, 11 Gauge, REF VCF-DDBAK-11. For use in Orthopedic / spinal procedures.; Lot: 19123262, 2007177415 units
Z-1714-202110 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), CODE INTVM-DSSKbd. For use in Orthopedic / spinal procedures.; Lot: 2001246, 19102741, 200127,56 units
Z-1715-202110G DIRECT SINGLE - ACCESS, CODE INTVM-DSBAK. For use in Orthopedic / spinal procedures.; Lot: 200512882 units
Z-1716-202110 GAUGE DIRECT ACCESS DIAMOND TIP, CODE: INTVM-DWCd. For use in Orthopedic / spinal procedures.; Lot: 11285ZV, 200120089 units
Z-1717-202111G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES) CODE: INTVMN-SCDK. For use in Orthopedic / spinal procedures.; Lot: 2001185, 20012437 units
Z-1718-202110 GAUGE CEMENT DELIVERY CANNULA, CODE: INTVM-CDC. For use in Orthopedic / spinal procedures.; Lot: 19112827, 2002440130 units
Z-1719-202111G DIRECT WORKING CANNULA DIAMOND TIP MINI, CODE: INTVMN-DWCD. For use in Orthopedic / spinal procedures.; Lot: 200243758 units
Z-1720-202110 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES, CODE: INTVM-SCDK. For use in Orthopedic / spinal procedures.; Lot: 20051290, 20081943, 20061420, 2002439122 units
Z-1721-2021ZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCF-SCDK. For use in Orthopedic / spinal procedures.; Lot: 2003661, 19113051, 20071709, 2007184372 units
Z-1722-2021ZVplasty Biopsy Device, 10 Gauge, REF VCF-1010. For use in Orthopedic / spinal procedures.; Lot: 20061369162 units
Z-1723-2021ZVplasty Biopsy Device, 11 Gauge, REF VCF-1010-11. For use in Orthopedic / spinal procedures.; Lot: 2006137034 units
Z-1724-2021ZVplasty Direct Access Bevel Tip Trocar, 11 Gauge, REF VCF-1022-11. For use in Orthopedic / spinal procedures.; Lot: 20061381, 20071771, 1912326398 units
Z-1725-2021ZVplasty Directional Cement Cannula Long, REF VCF-1080-L. For use in Orthopedic / spinal procedures.; Lot: 2006136527 units
Z-1726-2021ZVplasty Directional Cement Cannula (4 pieces per pack), REF VCF-1080-S4. For use in Orthopedic / spinal procedures.; Lot: 2006136611 units
Z-1727-202110G DIRECT SINGLE - ACCESS, CODE: INTV-DWCb. For use in Orthopedic / spinal procedures.; Lot: 2006143224 units
Z-1728-2021ZVplasty Direct Access Diamond Tip Trocar, 11 Gauge, REF VCF-1023-11. For use in Orthopedic / spinal procedures.; Lot: 19123264, 20071773113 units
Z-1729-2021ZVplasty Direct Bipedicular Bone Access Kit with Drill, 11 Gauge, REF VCF-DDBAK-11. For use in Orthopedic / spinal procedures.; Lot: 20071774, 1912326215 units
Z-1730-202110 G Coxaxial Cannula with Tuohy Connection, CODE: INTVM-CC. For use in Orthopedic / spinal procedures.; Lot: 2010249510 units
Z-1731-202110 Gauge Drill, CODE: INTVM-DRL. For use in Orthopedic / spinal procedures.; Lot: 2010248658 units
Z-1732-2021ZVplasty Cement Delivery Cannula, REF VCF-1007. For use in Orthopedic / spinal procedures.; Lot: 2010249022 units
Z-1733-202110G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures.; Pending—
Z-1734-202110G DIRECT SINGLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.; Pending—
Z-1735-202110G SINGLE CEMENT DELIVERY KIT (5 FILLERS). For use in Orthopedic / spinal procedures.; Pending—
Z-1736-202111G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures.; Pending—
Z-1737-202111G DIAMOND TROCAR/CANNULA. For use in Orthopedic / spinal procedures.; Pending—
Z-1738-202110G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.; Pending—
Z-1739-202111G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.; Pending—
Z-1740-202110G SINGLE CEMENT DELIVERY KIT (5 FILLERS). For use in Orthopedic / spinal procedures.; Pending—
Z-1741-202110G DOUBLE CEMENT DELIVERY KIT (8 FILLERS). For use in Orthopedic / spinal procedures.; Pending—
Z-1742-202110G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.; Pending—
Z-1743-202110G DIRECT SINGLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.; Pending—
Z-1744-202110 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES STERILE. For use in Orthopedic / spinal procedures.; Pending—
Z-1745-202110G COAXIAL CANNULA WITH TUOHY CONNECTION STERILE. For use in Orthopedic / spinal procedures.; Pending—
Z-1746-202110 GAUGE DRILL STERILE. For use in Orthopedic / spinal procedures.; Pending—
Z-1747-202110G CEMENT DELIVERY CANNULA. For use in Orthopedic / spinal procedures.; Pending—
Z-1748-202110G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures.; Pending—
Z-1749-202110 GAUGE DIRECT UNILATERAL STYLET (1 X DIAMOND 1 X BEVEL) STERILE. For use in Orthopedic / spinal procedures.; Pending—
Z-1750-2021CEMIX - CEMENT MIXING SYSTEM STERILE, CODE INTV-MMS. For use in Orthopedic / spinal procedures.; Lot: 2003787, 2001228197
Z-1751-2021InterV, 10G Kyphoplasty Kits, REF numbers: a) INTVM-10-DSK b) INTVM-10-SBK c) INTVM-15-DSK d) INTVM-15-DSKC e) INTVM-15-SBK f) INTVM-15-SIKBC g) INTVM-20-DSK h) INTVM-20-SBK. For use in Orthopedic / spinal procedures.; a) INTVM-10-DSK, lot numbers:13724ZV, 13517ZV, 13384ZV, 11658ZV, 12985ZV, 12259ZV, 11692ZV b) INTVM-10-SBK, lot numbers:12400ZV, 10784ZV, 14384ZV, 12329ZV, 11928ZV c) INTVM-15-DSK, lot numbers:12885ZV, 12108ZV, 11294ZV, 13761ZV, 11071ZV, 13908ZV, 13846ZV, 12193ZV, 11848ZV, 11624ZV, 11463ZV, 11035ZV, 10941ZV, 13410ZV, 13010ZV, 12654ZV, 12308ZV d) INTVM-15-DSKC, lot numbers:11489ZV, 11140ZV, 10904ZV e) INTVM-15-SBK, lot numbers:11219ZV, 11611ZV, 11538ZV f) INTVM-15-SIKBC, lot numbers:11725ZV, 11221ZV, 10988ZV, 10901ZV g) INTVM-20-DSK, lot numbers:11483ZV, 11250ZV h) INTVM-20-SBK, lot numbers:10954ZV, 11697ZV, 11704ZV503 units
Z-1752-2021InterV, 10G FLEX Kyphoplasty, REF Number: a) INTVM-15-FLDSK b) INTVM-20-FLDSK. For use in Orthopedic / spinal procedures.; a) INTVM-15-FLDSK, Lot Numbers:10342ZV, 12525ZV, 12267ZV, 12011ZV, 10545ZV, 10048ZV, 11861ZV, 11343ZV, 11037ZV, 10780ZV, 11102ZV b) INTVM-20-FLDSK, Lot Numbers: 10312ZV, 11698ZV, 10276ZV, 10205ZV, 10031ZV178 units
Z-1753-2021InterV CurvePlus Kit, REF Numbers: a) INTVMC-15-FLDSK b) INTVMC-20-FLDSK. For use in Orthopedic / spinal procedures.; a) INTVMC-15-FLDSK, Lot Numbers: 10659ZV b) INTVMC-20-FLDSK, Lot Numbers: 10312ZV, 11698ZV, 10276ZV, 10205ZV, 10031ZV36 units
Z-1754-2021InterV 10G Bone Access Tools/Kit, REF INTVM-FLNK. For use in Orthopedic / spinal procedures.; Lot Numbers: 11613ZV3 units
Z-1755-2021InterV 11G Kyphoplasty Kit, REF Numbers: a) INTVMN-10-DSK b) INTVMN-15-DSK c) INTVMN-15-DSKC d) INTVMN-20-DSK. For use in Orthopedic / spinal procedures.; a) INTVMN-10-DSK, Lot Numbers: 12200ZV b) INTVMN-15-DSK, Lot Numbers: 10816ZV, 13708ZV, 13845ZV, 13522ZV, 12133ZV c) INTVMN-15-DSKC, Lot Numbers: 11843ZV, 11412ZV, 11160ZV, 11017ZV d) INTVMN-20-DSK, Lot Numbers: 14266ZV, 14238ZV, 12524ZV, 11756ZV, 11083ZV119 units
Z-1756-2021OsteoFlex BONE CEMENT, REF Numbers: a) INTV-OSFL b) INTV-OSFL-LV. For use in Orthopedic / spinal procedures.; a) INTV-OSFL, Lot Numbers: 11395ZV, 11285ZV, 11574ZV, 11471ZV b) INTV-OSFL-LV, Lot Numbers: 12386ZV200 units
Z-1757-2021ZVplasty System, 10mm, Pat# VCF-1010-2. For use in Orthopedic / spinal procedures.; Lot Numbers: 13403ZV, 14172ZV, 13723ZV, 13031ZV, 10760ZV31 units
Z-1758-2021ZVplasty, 10G, 10mm Double Balloon Kit, REF VCF-1010-DBK. For use in Orthopedic / spinal procedures.; Lot Numbers: 12872ZV, 12406ZV, 11934ZV7 units
Z-1759-2021ZVplasty System, 15mm, Part# VCF-1015-1. For use in Orthopedic / spinal procedures.; Lot Numbers: 13378ZV, 11141ZV, 10815ZV, 13971ZV, 13921ZV, 13577ZV, 13133ZV, 13033ZV, 11793ZV, 11695ZV, 12132ZV, 14105ZV, 12280ZV, 14389ZV, 13884ZV, 11956ZV, 11470ZV, 11342ZV, 10902ZV, 10516ZV, 14358ZV, 12266ZV, 10866ZV, 10651ZV, 14207ZV, 14021ZV, 11231ZV, 11465ZV, 12025ZV, 11537ZV, 11415ZV, 10998ZV, 11072ZV, 13883ZV516 units
Z-1760-2021ZVplasty System, 15mm, Part# VCF-1015-1. For use in Orthopedic / spinal procedures.; Lot Numbers: 13378ZV, 11141ZV, 10815ZV, 13971ZV, 13921ZV, 13577ZV, 13133ZV, 13033ZV, 11793ZV, 11695ZV, 12132ZV, 14105ZV, 12280ZV, 14389ZV, 13884ZV, 11956ZV, 11470ZV, 11342ZV, 10902ZV, 10516ZV, 14358ZV, 12266ZV, 10866ZV, 10651ZV, 14207ZV, 14021ZV, 11231ZV, 11465ZV, 12025ZV, 11537ZV, 11415ZV, 10998ZV, 11072ZV, 13883ZV—
Z-1761-2021ZVplasty 10G, 15mm, Additional Level Kit, REF VCF-1015-1A. For use in Orthopedic / spinal procedures.; Lot Numbers: 12302ZV3 units
Z-1762-2021ZVplasty System, 15mm, Part Numbers: a) VCF-1015-2 b) VCF-1015-2A. For use in Orthopedic / spinal procedures.; a) VCF-1015-2, Lot Numbers: 13814ZV, 10950ZV, 11694ZV, 10953ZV, 10779ZV, 10588ZV, 13664ZV, 13469ZV, 13519ZV, 10825ZV, 13885ZV, 12989ZV, 10933ZV, 13758ZV, 14107ZV, 14206ZV, 14680ZV, 14022ZV, 11603ZV, 10505ZV b) VCF-1015-2A, Lot Numbers: 10515ZV, 14197ZV, 14114ZV, 14113ZV, 14024ZV, 14023ZV, 13641ZV, 13471ZV, 13325ZV195 units
Z-1763-2021ZVplasty 10G, FLEX KYPHOPLASTY, REF VCF-1015-FLEX. For use in Orthopedic / spinal procedures.; Lot Numbers: 14522ZV, 12260ZV, 12896ZV, 11557ZV19 units
Z-1764-2021ZVplasty 10G, 15mm Single Balloon Kit, REF VCF-SBK. For use in Orthopedic / spinal procedures.; Lot Numbers: 13877ZV, 13661ZV, 13388ZV, 12897ZV, 12764ZV, 12542ZV, 14391ZV, 14287ZV, 13004ZV, 10951ZV, 14016ZV79 units
Z-1765-2021ZVplasty 10G, 20mm, Traditional Unipedicular Kit, REF VCF-1020-1. For use in Orthopedic / spinal procedures.; Lot Numbers: 13978ZV, 13966ZV, 13873ZV, 13643ZV, 13185ZV, 12594ZV, 11766ZV, 11548ZV, 11391ZV, 11139ZV, 10781ZV, 14390ZV, 13976ZV, 13711ZV, 13413ZV, 12930ZV, 12331ZV, 12300ZV, 12199ZV, 14349ZV, 11271ZV, 11847ZV, 11274ZV302 units
Z-1766-2021ZVplasty System, 20mm, Part# VCF-1020-2. For use in Orthopedic / spinal procedures.; Lot Numbers: 13650ZV, 13518ZV, 11677ZV, 11678ZV, 10514ZV24 units
Z-1767-2021ZVPlasty, 11G, 15mm Traditional Bipedicular Kit, REF VCF-1115-2. For use in Orthopedic / spinal procedures.; Lot Numbers: 11958ZV, 14393ZV, 11726ZV, 11107ZV, 10955ZV49 units
Z-1768-2021OsteoFlex Cement and Mixing System, REF VCF-OSFL. For use in Orthopedic / spinal procedures.; Lot Numbers: 13844ZV, 12320ZV, 14359ZV, 14171ZV, 13887ZV, 12670ZV, 11759ZV, 11850ZV, 13750ZV, 14273ZV, 14017ZV, 13665ZV, 12766ZV, 12037ZV, 14100ZV, 11693ZV, 14472ZV, 14388ZV, 13651ZV, 13876ZV846 units
Z-1769-2021VERTEBREX SINGLE BALLOON KIT, REF VBRX-15-SBK-10. For use in Orthopedic / spinal procedures.; Lot Numbers: 10085ZV, 10086ZV, 11205ZV, 11217ZV, 11554ZV, 11558ZV, 11559ZV140 units
Z-1770-2021VERTEBREX SINGLE BALLOON KIT, REF VBRX-20-SBK-10. For use in Orthopedic / spinal procedures.; Lot Numbers: 11553ZV, 12276ZV, 9965ZV35 units
Based on the official FDA remedy

What to do — step by step

  1. Check Kit Sterility

    Verify if the kit was distributed as sterile by checking the packaging or manufacturer's documentation.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 2 years after the firm started it.

1. Firm started the recall: Mar 25, 202112. FDA classified it Class II: Jun 1, 202123. Published in FDA’s Enforcement Report: Jun 9, 202134. FDA terminated the recall: Mar 20, 2023420212023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Keep exploring

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1738-2021 (March 25, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1738-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA