FDA-Device2023-04-19Class II
stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in a Partial Knee Arthroplasty surgical procedure
Howmedica Osteonics Corp.
Hazard
Certain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking
Sold states
U.S., Netherlands, Japan, China, India, Korea, and Australia.
Affected count
102 units
Manufactured in
325 Corporate Dr, N/A, Mahwah, NJ, United States
Products
stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in a Partial Knee Arthroplasty surgical procedure
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1386-2023Don't want to check this manually?
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