Stryker Locking Screw Recall: Blister Pack Sterility Risk

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Recalling firmStryker GmbHBohnackerweg 1 · Selzach, N/A

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Stryker is recalling certain locking screws used in bone implants because the blister pack might not stay sterile. This could lead to infections if the screws are used without proper sterility.

Why it’s dangerous

The blister pack that holds the screws may become compromised, meaning the screws might not be sterile when used. This could cause infections in patients during surgery.

Who’s affected

Orthopedic surgeons and medical staff who use these screws for bone fixation. Patients receiving these implants are at risk if the screws are not sterile.

How to tell if you have this one

Check for catalog number 18965045S and lot numbers K02C1BB, K03033E, K030342, K03035D, K030F17, K030F1D, K031B6E, K031B70, or K0328A5 on the packaging.

Brand
Stryker
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for catalog number 18965045S and the listed lot numbers on the packaging to confirm if your item is affected.

✎ GovInfoNow

Questions people ask

Why is this screw being recalled?

The blister pack may not stay sterile, which could lead to infections if the screws are used without proper sterility.

How can I tell if my screw is affected?

Check for catalog number 18965045S and lot numbers K02C1BB through K0328A5 on the packaging.

What should I do if I have the affected screws?

The recall record does not specify a remedy, so contact Stryker directly for guidance.

Take action

Contact Stryker

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

✉️ Open in email

Subject: Recall Z-2385-2020 — Stryker Stryker

Hello,

I own a Stryker that is covered by recall Z-2385-2020 from Stryker.

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-2385-2020 (May 7, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2385-2020 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.

Stryker GmbH recalls Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x45 mm Catalog Number: 18965045S - Product Usage: Stryker implants are

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