Howmedica Osteonics 28MM-4 LFIT V40 Head Recall: Tyvek Lid May Debond
Howmedica Osteonics recalls 28MM-4 LFIT V4:10 heads with catalog number 6260-9-122 due to potential Tyvek lid debonding from sealed packaging.
Lower-risk recall
There is a potential for the outer white Tyvek lid to debond from the sealed package.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/61669-howmedica-osteonics-28mm-4-lfit-v40-head-recall-tyvek-lid.
Source Summary by GovInfoNow · govinfonow.com/recall/61669-howmedica-osteonics-28mm-4-lfit-v40-head-recall-tyvek-lid · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0314-2022
Cite this page
“Howmedica Osteonics 28MM-4 LFIT V40 Head Recall: Tyvek Lid May Debond.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61669-howmedica-osteonics-28mm-4-lfit-v40-head-recall-tyvek-lid. Based on FDA recall #Z-0314-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0314-2022%22&limit=1).
Why it’s dangerous
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.
Who’s affected
Patients using this specific type of hip replacement head are likely affected. Those who have recently received this product are at the highest risk.
How to tell if you have this one
Check for the catalog number 6260-9-122 on the product. The affected units were sold with lot numbers 86604305 or 86604306.
- Brand
Howmedica Osteonics- Product
28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-122- 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
Puerto Rico
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0313-2022 | 28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-028; UDI number - (01) 07613327012996(17)261913(10); lot numbers - 86953401, 86953503 | — |
| Z-0314-2022 | 28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-122; UDI number - (01) 07613327013016(17)261013(10); lot numbers - 86604305, 86604306 | — |
What to do — step by step
Check Product Details
Verify the catalog number 6260-9-122 and lot numbers 86604305 or 86604306 on the product.
Where it went and when
Where it was distributed
Distributed in Puerto Rico.
FDA distribution: “Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Puerto Rico.
Recall timeline
FDA published this recall 54 days 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.
Questions people ask
Is this product dangerous if used?
The recall states there is a potential for the Tyvek lid to debond, but the product is not considered dangerous if used properly.
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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-0314-2022 (October 15, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0314-2022 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.