Zimmer CBS 4.0 Countersink Recall: Possible Material Defect

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Recalling firmZimmer GmbHSulzerallee 8, N/A · Winterthur, N/A N/A

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Zimmer is recalling CBS 4.0 countersink screws marked with "Normed" because they might be made from an incorrect material. This could mean the screws don't meet the intended specifications.

Why it’s dangerous

The screws might be made from a different material than specified, which could affect their performance in medical procedures. This material mismatch may lead to improper function or failure during surgery.

Who’s affected

Surgical instrument users who own the recalled CBS 4.0 countersink screws marked with "Normed". Surgeons and medical professionals using these screws are most at risk.

How to tell if you have this one

Check for the "Normed" marking on the screw. The product is a CBS 4.0 countersink, cannulated, 30mm stop, AO, with item number 503004353.

Brand
Zimmer
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Marking
Look for the "Normed" marking on the screw to confirm if it's affected.

✎ GovInfoNow

Questions people ask

Why is this product being recalled?

The investigation found the products might be made from a different material than specified in the applicable standards.

What should I do if I have this product?

The recall does not specify a remedy, so check the marking and contact Zimmer if you have concerns.

How can I tell if my screw is affected?

Screws marked with "Normed" are affected. The product is a CBS 4.0 countersink, cannulated, 30mm stop, AO, with item number 503004353.

Take action

Contact Zimmer

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

✉️ Open in email

Subject: Recall Z-1459-2019 — Zimmer Zimmer

Hello,

I own a Zimmer that is covered by recall Z-1459-2019 from Zimmer.

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-1459-2019 (April 8, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1459-2019 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.

Zimmer GmbH recalls CBS 4.0 countersink, cannulated, 30mm stop, AO, Item Number 503004353

Lower-risk recall