Device product
stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in a Partial Knee Arthroplasty surgical procedure
Z-1386-2023
Product summary
- Event
- Event 91913
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 102 units
- Official record key
device-enforcement:Z-1386-2023
Official wording
Reason: Certain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking
Code information: GTIN 00848486003753, Lot Number 26250421
Distribution pattern: U.S., Netherlands, Japan, China, India, Korea, and Australia.
Derived failure modes
-
Unknown
Certain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking