Zimmer recalls MaxiCan 4.5 countersink screws with "Normed" marking due to possible material deviation from specifications. Affected items may not meet intended performance standards.
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Zimmer is recalling MaxiCan 4.5 countersink screws marked with "Normed" because they might be made from an incorrect material. This could affect their performance and safety in medical procedures.
The screws might not meet the intended material specifications, which could lead to improper performance during surgery. This could potentially cause issues with the surgical outcome or device function.
Medical professionals using these screws for surgical procedures are most at risk. Patients receiving surgery with affected screws may experience complications.
Check for the "Normed" marking on the screw packaging or product label. Affected items are identified by the specific item number 503004177 and the "Normed" label.
Look for the "Normed" marking on the screw to confirm if it's affected.
The specific item number is 503004177, and affected screws have the "Normed" marking.
The recall does not require immediate stop use; check for the "Normed" marking to determine if affected.
Contact Zimmer directly to confirm if your screws are affected and follow their guidance.
We’ve drafted a message you can send Zimmer to request your refund or repair — edit it as you like.
Subject: Recall Z-1454-2019 — Zimmer Zimmer Hello, I own a Zimmer that is covered by recall Z-1454-2019 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.