Recall archive / FDA device enforcement
NexGen Precoat Stemmed Tibial Plate Size 5 — FDA record Z-2092-2023
Reported terminated
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 May 19, 2023. 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
- NexGen Precoat Stemmed Tibial Plate Size 5
- Reason
- Device outer packaging was incorrectly labeled.
- Classification
- Class II
- Recalling firm
- Zimmer, Inc.
- Quantity
- N/A
- Agency-reported status
- Terminated
- Source record identifier
- Z-2092-2023
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 | Model No. 00598004701; UDI No./Lot. No.: (01)00889024217607(17)321228(10)J7418537/J7418537 and (01)00889024217607(17)321228(10)J7418542/J7418542. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
International distribution in the country of India.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Jul 12, 2023
- Recall initiation date
- May 19, 2023
- Center classification date
- Jul 5, 2023
- Termination date
- May 29, 2026
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.