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Lower risk Medical device recall · FDA · Published January 24, 2024

Synthes Opal Spine Implant Recall: Unsterilized Risk

Synthes recalls unsterilized Opal spinal implants (part 08.803.231S) due to sterility risks. Affected units may cause infection or complications if used without proper sterilization.

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

🇺🇸 FDA recall #Z-1242-2024Medical deviceSynthes ›
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Contact the company

Recalling firmSynthes (USA) Products LLC1301 Goshen Pkwy · West Chester, PA 19380-5986
✎ GovInfoNow plain-language explainer

Synthes is recalling certain spinal implants (Opal cages) because they weren't properly sterilized. Using these implants without confirmed sterility could lead to infections or complications. Read more at govinfonow.com/recall/56259-synthes-opal-spine-implant-recall-unsterilized-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/56259-synthes-opal-spine-implant-recall-unsterilized-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1242-2024

Cite this page

“Synthes Opal Spine Implant Recall: Unsterilized Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/56259-synthes-opal-spine-implant-recall-unsterilized-risk. Based on FDA recall #Z-1242-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1242-2024%22&limit=1).

Synthes (USA) Products LLC recalled one Opal Intervertebral Cage model due to unsterilized products where sterility cannot be confirmed, according to the FDA on Jan. 24, 2024.

How to tell if you have it

  • Brand: Synthes
  • Product: Opal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable
  • Part Number: 08.803.231S
  • Lot Number: 427P153

The hazard

The recalled devices were not sterilized and sterility cannot be confirmed, according to the FDA.

Context

GovInfoNow's records show Synthes (USA) Products LLC has 19 other recalls on record since July 21, 2017. Other recent recalls of similar products include Medical Action Industries Epidural Kits Recall: Compromised Sterility Risk (July 23, 2026), Howmedica SCORPIO Patella Implants Recall: Oxidation Risk (July 30, 2026), and Argon Medical Devices General Biospy Tray Recall: Sterility Risk (June 1, 2026).

How to tell if you have this one

Check for part number 08.803.231S and lot number 427P153 on the implant. The product was sold with a unique device identifier (UDI) 07611819318489.

  • Brand
    Synthes
  • Category
    Medical device
FDA recall event · 9 products

All 9 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
    Ongoing
  • Distribution
    Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Canada, Czech Republic, Germany, Spain, Finland, France, United Kingdom, Ireland, South Korea, Kuwait, Mexico, Netherlands, Slovakia, Taiwan, South Africa.
Recall numberProduct, codes & lotsQuantity
Z-1234-202413 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. Part Number: 04.008.378S; UDI: 10886982087331 Lot Number: 41P22225 units
Z-1235-20241.5MM Drill Bit/QC/85MM Sterile-surgical, orthopedic, pneumatic powered & accessory/attachment Part Number: 310.15S; UDI: 10886982186034 Lot Number: 19P436417 units
Z-1236-20242.5MM DRILL BIT/QC/GOLD/110MM STERILE-surgical, orthopedic, pneumatic powered & accessory/attachment Product Code: 310.25S; UDI: 10886982186324 Lot Number: 77P650630 units
Z-1237-2024RIA Tube Assembly, minimum 520 mm length, sterile- intended for use in adults and adolescents (12-21 years) to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis, to harvest finely morselized autogenous bone and bone marrow for any surgical procedure requiring bone graft to facilitate fusion and/or fill bone defects, and to remove infected and necrotic bone and tissue from the medullary canal in the treatment of osteomyelitis. Part Number: 314.746S; UDI: 10886982189080 Lot Number: H802995, H803000, H803020, H830033144 units
Z-1238-2024RAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing fracture repair and reconstructive procedures of the craniofacial skeleton (excluding the upper and lower jaw) in pediatric and adult populations. Part Number: 530.553.01S; UDI: 10887587057262 Lot Number: 499P37110 units
Z-1239-2024TFNA Femoral Nail 9mm, right, 130¿, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.944S; UDI: 10886982098047 Lot Number: 3744P3711 units
Z-1240-2024TFNA Femoral Nail 11mm, right, 130¿, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.144S; UDI: 10886982096562 Lot Number: 4489P9811 units
Z-1241-2024VA-LCP Clavicle Plate 2.7, shaft, CS1, right-Intended for fixation of clavicle bone fragments. Part Number: 02.112.621S; UDI: 10886982279118 Lot Number: 1201P1247 units
Z-1242-2024Opal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenerative spine disease Part Number: 08.803.231S; UDI: 07611819318489 Lot Number: 427P15330 units
Based on the official FDA remedy

What to do — step by step

  1. Contact Manufacturer

    Reach out to Synthes (USA) Products LLC for guidance on next steps for affected implants.

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 and the countries of Argentina, Austria, Australia, Belgium, Canada, Czech Republic, Germany, Spain, Finland, France, United Kingdom, Ireland, South Korea, Kuwait, Mexico, Netherlands, Slovakia,…” 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 published this recall 49 days after the firm started it.

1. Firm started the recall: Jan 24, 202412. FDA classified it Class II: Mar 1, 202423. Published in FDA’s Enforcement Report: Mar 13, 202432024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

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-1242-2024 (January 24, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1242-2024 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 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