Zimmer recalls Osteofresh arthrodesis drills with "Normed" marking due to possible material deviation from specifications. Affected items may not meet safety standards.
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Zimmer is recalling Osteofresh arthrodesis drills that were marked with "Normed" because they might be made from a different material than specified. This could affect the drill's safety and performance during medical procedures.
The drills might be made from a different material than specified, which could lead to improper function during surgical procedures. This material deviation may affect the drill's precision and safety in medical applications.
Medical professionals using the Osteofresh arthrodesis drills with "Normed" markings are likely affected. Patients undergoing surgery with these drills may be at risk if the material deviation impacts procedure safety.
Check for the "Normed" marking on the drill's label. Affected items are specifically identified as Osteofresh arthrodesis drills with this marking.
Look for the "Normed" marking on the drill to confirm if it is affected.
The recall is due to possible material deviation from specifications, which could affect the drill's safety and performance during medical procedures.
Check for the "Normed" marking on the drill's label. Affected items are specifically identified as Osteofresh arthrodesis drills with this marking.
The recall record does not specify a remedy, so no action is required beyond checking the label.
We’ve drafted a message you can send Zimmer to request your refund or repair — edit it as you like.
Subject: Recall Z-1431-2019 — Zimmer Zimmer Hello, I own a Zimmer that is covered by recall Z-1431-2019 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.
