Recall archive / FDA device enforcement
stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intended for use in a Partial Knee Arthroplasty... — FDA record Z-1385-2023
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 Mar 10, 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
- stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intended for use in a Partial Knee Arthroplasty surgical procedure
- Reason
- Ccertain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking
- Classification
- Class II
- Recalling firm
- Howmedica Osteonics Corp.
- Quantity
- 52 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1385-2023
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 | GTIN 00848486003746, Lot Number 26270421 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
U.S., Netherlands, Japan, China, India, Korea, and Australia.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Apr 19, 2023
- Recall initiation date
- Mar 10, 2023
- Center classification date
- Apr 12, 2023
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.