Howmedica Osteonics recalls 32MM V40 Taper Vit Head implants with potential packaging de-bonding. Affected units may have outer Tyvek lid separating from sealed package.
There is a potential for the outer Tyvek lid to de-bond from the sealed package.
Howmedica Osteonics is recalling a specific hip implant model due to a potential risk that the outer packaging could separate from the sealed package. This could lead to the implant being exposed to environmental factors before use.
The outer Tyvek lid of the sealed package may de-bond from the package during storage or shipping. This could expose the implant to environmental contaminants before use, though it doesn't pose an immediate safety risk during normal use.
Patients who received the 32MM -4 V40 TAPER VIT HEAD implant with catalog number 626:5-032 are likely affected. Those who have this implant in their hip joint are at risk.
Check for the product name '32MM -4 V40 TAPER VIT HEAD' with catalog number 6260-5-032. The lot number 87327407 is also associated with this recall.
Inspect the outer Tyvek lid for separation from the sealed package. If it has de-bonded, contact Howmedica Osteonics for guidance.
The recall indicates a potential for the packaging to de-bond, but it does not pose an immediate safety risk during normal use. The hazard is low risk.
Check for the product name '32MM -4 V40 TAPER VIT HEAD' with catalog number 6260-5-032 and lot number 87327407.
Inspect the packaging for de-bonded Tyvek lid. If found, contact Howmedica Osteonics for further instructions.
We’ve drafted a message you can send Howmedica Osteonics to request your refund or repair — edit it as you like.
Subject: Recall Z-0644-2022 — Howmedica Osteonics Howmedica Osteonics Hello, I own a Howmedica Osteonics that is covered by recall Z-0644-2022 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.