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Howmedica Osteonics Corp. recalls stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in a Partial Knee Arthroplasty su
Recalled April 19, 2023 · FDA recall Z-1386-2023 · Howmedica Osteonics
Hazard
Certain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking · FDA Class II
Units
102 units
Sold at
U.S., Netherlands, Japan, China, India, Korea, and Australia.
Description
Certain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking
Product
stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in a Partial Knee Arthroplasty surgical procedure
Manufacturer(s)
Howmedica Osteonics Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →