Howmedica Osteonics recalls 28MM-4 LFIT V4:10 heads with catalog number 6260-9-122 due to potential Tyvek lid debonding from sealed packaging.
There is a potential for the outer white Tyvek lid to debond from the sealed package.
Howmedica Osteonics is recalling 28MM-4 LFIT V40 heads with specific catalog numbers because the outer white Tyvek lid might separate from the sealed package. This could lead to the product being damaged or improperly handled during use.
The outer white Tyvek lid may separate from the sealed packaging, potentially causing the product to become damaged or improperly handled. This could affect the product's integrity and safety during use.
Patients using this specific type of hip replacement head are likely affected. Those who have recently received this product are at the highest risk.
Check for the catalog number 6260-9-122 on the product. The affected units were sold with lot numbers 86604305 or 86604306.
Verify the catalog number 6260-9-122 and lot numbers 86604305 or 86604306 on the product.
The recall states there is a potential for the Tyvek lid to debond, but the product is not considered dangerous if used properly.
Check for catalog number 6260-9-122 and lot numbers 86604305 or 86604306 on the product.
The recall does not specify a remedy, so no action is required unless you suspect the lid has debonded.
We’ve drafted a message you can send Howmedica Osteonics to request your refund or repair — edit it as you like.
Subject: Recall Z-0314-2022 — Howmedica Osteonics Howmedica Osteonics Hello, I own a Howmedica Osteonics that is covered by recall Z-0314-2022 from Howmedica Osteonics. 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.
