Synthes Opal Spine Implant Recall: Unsterilized Risk

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Recalling firmSynthes (USA) Products LLC1301 Goshen Pkwy · West Chester, PA 19380-5986

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✎ GovInfoNow plain-language explainer

What happened, in plain English

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.

Why it’s dangerous

The implants were not sterilized properly, meaning they could contain harmful bacteria. If used in surgery without confirmed sterility, this could lead to infections or complications in the patient.

Who’s affected

Patients who received the Opal spinal implant with part number 08.803.231S or lot number 427P153 are affected. Medical professionals using these implants for spinal surgery are at higher risk.

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

Based on the official FDA remedy

What to do — step by step

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

✎ GovInfoNow

Questions people ask

Are these implants safe to use?

No, the implants were not sterilized properly, so they could contain harmful bacteria and pose infection risks.

How can I check if my implant is affected?

Look for part number 08.803.231S and lot number 427P153 on the implant. The product also has a unique device identifier (UDI) 07611819318489.

What should I do if I have this implant?

Contact Synthes (USA) Products LLC directly for instructions on next steps.

Take action

Contact Synthes

We’ve drafted a message you can send Synthes to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1242-2024 — Synthes Synthes

Hello,

I own a Synthes that is covered by recall Z-1242-2024 from Synthes.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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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.

Synthes (USA) Products LLC recalls Opal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenerative spine disease Part Number: 08.803.231S

Lower-risk recall