Zimmer recalls CBS 4.0 countersink tools with "Normed" marking due to possible material mismatch. Affected items may not meet specifications.
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Zimmer is recalling CBS 4.0 countersink tools that have a "Normed" marking. These tools might be made from an incorrect material, which could affect their performance and safety.
The tools may be manufactured from a different material than specified, which could lead to improper function. This might cause tools to behave unexpectedly during surgical procedures, though serious injury is not indicated.
Orthopedic surgeons and medical professionals who use Zimmer's CBS 4.0 countersink tools with the "Normed" marking. Those most at risk are users who rely on precise tool specifications for surgical procedures.
Check if the tool has a "Normed" marking on it. The product is part of Zimmer's CBS 4.0 countersink line with item number 503004352.
Look for the "Normed" marking on the tool to confirm if it's affected.
The investigation found that the tools might be made from a different material than specified in the product standards.
Check if the tool has a "Normed" marking. If it does, contact Zimmer for guidance.
The recall states a possible material mismatch, but no specific risk of serious injury is mentioned.
We’ve drafted a message you can send Zimmer to request your refund or repair — edit it as you like.
Subject: Recall Z-1458-2019 — Zimmer Zimmer Hello, I own a Zimmer that is covered by recall Z-1458-2019 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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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.
