Zimmer recalls NexGen Precoat Stemmed Tibial Plate Size 5 due to incorrect outer packaging labeling. No action needed as the hazard is a labeling error, not a safety issue.
Device outer packaging was incorrectly labeled.
Zimmer is recalling NexGen Precoat Stemmed Tibial Plate Size 5 because the outer packaging was incorrectly labeled. This labeling error does not pose a safety risk and requires no action from users.
The device's outer packaging was labeled incorrectly, which could lead to confusion during product identification. However, this labeling error does not affect the device's safety or functionality.
Orthopedic surgeons and medical facilities that purchased the NexGen Precoat Stemmed Tibial Plate Size 5 with the incorrect labeling. Patients using this device are not at risk.
Check the outer packaging for the model number 00598004701 and UDI/Lot numbers starting with (01)00889024217607(17)321228(10)J7418537 or J7418542. This specific labeling error does not impact device safety.
Check the outer packaging for the model number 00598004701 and UDI/Lot numbers starting with (01)00889024217607(17)321228(10)J7418537 or J7418542.
No, this recall is for a labeling error that does not affect device safety or functionality.
No action is needed as the labeling error does not pose a safety risk.
Check the outer packaging for the model number 00598004701 and UDI/Lot numbers starting with (01)00889024217607(17)321228(10)J7418537 or J7418542.
We’ve drafted a message you can send Zimmer to request your refund or repair — edit it as you like.
Subject: Recall Z-2092-2023 — Zimmer Zimmer Hello, I own a Zimmer that is covered by recall Z-2092-2023 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.
