Recall archive / FDA device enforcement
28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-122 — FDA record Z-0314-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 15, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-122
- Reason
- There is a potential for the outer white Tyvek lid to debond from the sealed package.
- Classification
- Class II
- Recalling firm
- Howmedica Osteonics Corp.
- Quantity
- Not supplied
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0314-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI number - (01) 07613327013016(17)261013(10); lot numbers - 86604305, 86604306 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Puerto Rico
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Dec 8, 2021
- Recall initiation date
- Oct 15, 2021
- Center classification date
- Nov 30, 2021
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.