Zimmer recalls V-TEK standard-countersink cannulated AO items with "Normed" marking due to possible material mismatch in specifications. Affected items may not meet intended standards.
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Zimmer is recalling V-TEK standard-countersink cannulated AO items with "Normed" markings because they might be made from an incorrect material. This could affect the item's performance and safety.
The products may have been manufactured from a different material than specified, which could lead to improper performance in surgical applications. This material mismatch might affect the item's functionality but does not pose an immediate safety hazard.
Orthopedic surgeons and medical professionals who use these surgical implants are likely affected. The risk is low as the hazard involves material mismatch rather than immediate safety risks.
Check for items marked with "Normed" on the V-TEK standard-countersink cannulated AO products. The affected items have Item Number ST28.66.111.
Look for the "Normed" marking on the V-TEK standard-countersink cannulated AO item.
The products may have been manufactured from a different material than defined in the applicable specifications.
Check for the "Normed" marking on the item. If present, it is affected and should be checked for proper material compliance.
The recall record does not mention any remedy or corrective action.
We’ve drafted a message you can send Zimmer to request your refund or repair — edit it as you like.
Subject: Recall Z-1466-2019 — Zimmer Zimmer Hello, I own a Zimmer that is covered by recall Z-1466-2019 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.