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Lower risk Medical device recall · FDA · Published March 14, 2019

Nobel Biocare Guided Start Drills Recall: Risk of Contaminated Sterilized Devices

Nobel Biocare recalls Guided Start Drills due to potential contamination from packaging issues. Devices may not stay sterile during shelf life, risking infection. Affected units include specific model numbers.

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

🇺🇸 FDA recall #Z-1302-2020Medical deviceNobel Biocare ›
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Contact the company

Recalling firmNobel Biocare Usa Llc22715 Savi Ranch Pkwy · Yorba Linda, CA 92887-4609
✎ GovInfoNow plain-language explainer

Nobel Biocare is recalling Guided Start Drills that could become contaminated during storage. This poses a risk of infection if the devices are used in medical procedures after the recall date. Read more at govinfonow.com/recall/68814-nobel-biocare-guided-start-drills-recall-risk-of-contaminated-sterilized.

Source Summary by GovInfoNow · govinfonow.com/recall/68814-nobel-biocare-guided-start-drills-recall-risk-of-contaminated-sterilized · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1302-2020

Cite this page

“Nobel Biocare Guided Start Drills Recall: Risk of Contaminated Sterilized Devices.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68814-nobel-biocare-guided-start-drills-recall-risk-of-contaminated-sterilized. Based on FDA recall #Z-1302-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1302-2020%22&limit=1).

Nobel Biocare Usa Llc recalled Guided Start Drills/Counterbore NobRpl NP due to potential loss of sterility during shelf-life, the FDA said on 2019-03-14. The Class II recall was voluntarily initiated by the firm.

How to tell if you have it

  • Guided Start Drills/Counterbore NobRpl NP - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered
  • UPC 07332747005295

The hazard

Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.

Context

GovInfoNow's records show Nobel Biocare Usa Llc has 6 other recalls on record since 2018-03-16. Other recent recalls include NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 (2021-12-17), Nobel Biocare Dental Implant Recall (2019-08-28), and Nobel Biocare Temporary Abutment Screws May Loosen - Recall (2019-08-09). Other recent recalls of similar products include Medline Convenience Kits Recall (2026-01-07), Medline IV Start Kits Recalled Due to Sterility Risk in Packaging (2026-06-12), and Boston Scientific EndoVive Safety PEG Kit Recall (2026-02-10).

How to tell if you have this one

Check for model numbers 32737 or the specific catalog number (01)07332747005295(10)73425 on the packaging. The product is used for dental procedures to prepare osteotomies.

  • Brand
    Nobel Biocare
  • Product
    Guided Start Drills/Counterbore NobRpl NP
  • Category
    Medical device
FDA recall event · 24 products

All 24 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
    Worldwide distribution - US Nationwide distribution and countries of CA, AU, JP, BR, ZA, RU, TW, HK, IN, CN, SA, NZ, MO, CO, LB, AT, BE, CH, CY, DE, DK, EE, ES, FI, FR, GB, GG, GR, HR, HU, IE, LT, LU, NL, PL, PT, RS, SE.
Recall numberProduct, codes & lotsQuantity
Z-1302-2020Guided Start Drills/Counterbore NobRpl NP - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants; (01)07332747005295(10)73425 Catalog# 32737None
Z-1303-2020Drill Tapered NP 3.5x8 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.; (01)07332747065756(10)73466 Catalog# 370458 units
Z-1304-2020Dense Bone Drill 6.0 6x16 mm Single-Pat- Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.; (01)07332747065756(10)73502 Catalog# 370498 units
Z-1305-2020Screw Tap Tapered WP Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.; (01)07332747065701(10)73499 Catalog# 37052None
Z-1306-2020Drill Tapered NP 3.5x10 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.; (01)07332747065688(10)73415 (01)07332747065688(10)73537 Catalog# 37075—
Z-1307-2020Drill Tapered NP 3.5x11.5 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.; (01)07332747065671(10)73280 Catalog# 37076473 units
Z-1308-2020Drill Tapered RP 4.3x10 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.; (01)07332747065633(10)73433 (01)07332747065633(10)73495 Catalog# 37080346 units
Z-1309-2020Drill Tapered RP 4.3x11.5 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.; (01)07332747065626(10)73474 (01)07332747065626(10)73369 Catalog# 37081260 units
Z-1310-2020Drill Tapered RP 4.3x13 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.; (01)07332747065619(10)73274 Catalog# 37082154 units
Z-1311-2020Drill Tapered WP 5x10 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement.; (01)07332747065589(10)73287 (01)07332747065589(10)73428 Catalog# 37085264 units
Z-1312-2020Drill Tapered WP 5x11.5 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement.; (01)07332747065572(10)73451 Catalog# 3708659 units
Z-1313-2020Drill Tapered 6.0 6x8 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement.; (01)07332747065541(10)73575 Catalog# 37089None
Z-1314-2020Dense Bone Drill NP 3.5x16 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement.; (01)07332747065480(10)73574 Catalog# 37095None
Z-1315-2020Dense Bone Drill WP 5x13 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement.; (01)07332747065459(10)73591 Catalog# 37098None
Z-1316-2020Implant Retrieval Instrument Hex & Tri-Ch NP/RP 22mm - Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal conical connection, internal tri-channel connection or external hex connection.; (01)07332747083767(10)73491 (01)07332747083767(10)73600 (01)07332747083767(10)73296 (01)07332747083767(10)73315 (01)07332747083767(10)73595 Catalog# 374712470 units
Z-1317-2020Implant Retrieval Instrument Hex & Tri-Chi NP/RP 31mm - Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal conical connection, internal tri-channel connection or external hex connection.; (01)07332747083774(10)73303 Catalog# 37472 & Tri-Chi197 units
Z-1318-2020Implant Retrieval Instrument CC 3.0 31 mm- Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal conical connection, internal tri-channel connection or external hex connection.; (01)07332747083781(10)73306 Catalog# 3747331 units
Z-1319-2020Implant Retrieval Instrument CC NP & Ext Hex WP 22 mm - Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal conical connection, internal tri-channel connection or external hex connection.; (01)07332747083798(10)73614 (01)07332747083798(10)73256 Catalog# 37474423 units
Z-1320-2020Implant Retrieval Instrument CC RP & Tri Ch Hex WP 22 mm - Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal conical connection, internal tri-channel connection or external hex connection.; (01)07332747083804(10)73601 (01)07332747083804(10)73298 Catalog# 37475526 units
Z-1321-2020Implant Retrieval Instrument Tri Channel 6.0 22 mm - Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal conical connection, internal tri-channel connection or external hex connection.; (01)07332747083811(10)73313 Catalog# 3747611 units
Z-1322-2020Abutment Screw Retrieval Instrument 3.0/NP - Product Usage: The instruments for abutment screw retrieval can be used if an abutment screw is broken and a part of the screw is left inside the implant screw channel. If the implant thread needs to be cleaned before placing a new screw, a screw tap repair can be used. The instruments are intended for both simple and advanced treatments.; (01)07332747084085(10)73585 (01)07332747084085(10)73430 Catalog # 37503233 units
Z-1323-2020Implant Retrieval Kit - Product Usage: The kit itself does not have a specific intended Use, but included devices have specific intended use as shown above.; 857717 (01)07332747083750(10)857717 28-Dec-2018 857597 (01)07332747083750(10)857597 31-Aug-2018 857656 (01)07332747083750(10)857656 22-Oct-2018 818712 (01)07332747083750(10)818712 9-Nov-2018 818747 (01)07332747083750(10)818747 9-Nov-2018 818647 (01)07332747083750(10)818647 10-Oct-2018 857578 (01)07332747083750(10)857578 23-Aug-2018 857610 (01)07332747083750(10)857610 10-Sep-2018 857615 (01)07332747083750(10)857615 13-Sep-2018 857653 (01)07332747083750(10)857653 10-Oct-2018 857677 (01)07332747083750(10)857677 7-Nov-2018 857694 (01)07332747083750(10)857694 3-Dec-2018 857708 (01)07332747083750(10)857708 14-Dec-2018 857711 (01)07332747083750(10)857711 20-Dec-2018 857729 (01)07332747083750(10)857729 8-Jan-2019 857732 (01)07332747083750(10)857732 15-Jan-2019 818682 (01)07332747083750(10)818682 5-Nov-2018 818811 (01)07332747083750(10)818811 18-Dec-2018 Catalog# 3747087 units
Z-1324-2020Abutment Screw Retrieval Kit - Product Usage: The kit itself does not have a specific intended Use, but included devices have specific intended use as shown above.; (01)07332747083866(10)818727 (01)07332747083866(10)818683 Catalog# 374817 units
Z-1325-2020Abutment Screw Retrieval Instrument RP/WP/6.0 - Product Usage: The instruments for abutment screw retrieval can be used if an abutment screw is broken and a part of the screw is left inside the implant screw channel. If the implant thread needs to be cleaned before placing a new screw, a screw tap repair can be used. The instruments are intended for both simple and advanced treatments.; (01)07332747084092(10)73562 Catalog# 37504132 units
Based on the official FDA remedy

What to do — step by step

  1. Check Packaging

    Look for the model number 32737 or catalog number (01)07332747005295(10)73425 on the packaging.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

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: “Worldwide distribution - US Nationwide distribution and countries of CA, AU, JP, BR, ZA, RU, TW, HK, IN, CN, SA, NZ, MO, CO, LB, AT, BE, CH, CY, DE, DK, EE, ES, FI, FR, GB, GG, GR, HR, HU, IE, LT, LU, NL, PL, PT, RS, SE.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 4.9 years after the firm started it.

1. Firm started the recall: Mar 14, 201912. FDA classified it Class II: Feb 19, 202023. Published in FDA’s Enforcement Report: Feb 26, 202034. FDA terminated the recall: Feb 15, 2024420192024
  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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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-1302-2020 (March 14, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1302-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on August 20, 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