Howmedica Osteonics 32MM V40 Taper Vit Head Recall: Packaging De-bond Risk
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.
Lower-risk recall
There is a potential for the outer Tyvek lid to de-bond from the sealed package.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/61412-howmedica-osteonics-32mm-v40-taper-vit-head-recall-packaging-de.
Source Summary by GovInfoNow · govinfonow.com/recall/61412-howmedica-osteonics-32mm-v40-taper-vit-head-recall-packaging-de · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0644-2022
Cite this page
“Howmedica Osteonics 32MM V40 Taper Vit Head Recall: Packaging De-bond Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61412-howmedica-osteonics-32mm-v40-taper-vit-head-recall-packaging-de. Based on FDA recall #Z-0644-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0644-2022%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Howmedica Osteonics- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Worldwide distribution - US Puerto Rico and the countries of Canada, and Malaysia.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0644-2022 | 32MM -4 V40 TAPER VIT HEAD, Catalog Number 6260-5-032; UDI: 07613327012842; Lot Number: 87327407 | 8 units |
| Z-0645-2022 | Dall Miles SM GRIP AND 2 1.6MM HOMOG CBL, Catalog Number 6704-0-110; UDI: 07613327013306; Lot Number: 87458602 | 1 unit |
What to do — step by step
Check Packaging Condition
Inspect the outer Tyvek lid for separation from the sealed package. If it has de-bonded, contact Howmedica Osteonics for guidance.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Puerto Rico and the countries of Canada, and Malaysia.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-0644-2022 (December 21, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0644-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.