FDA recall Z-1386-2023

Product

stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in a Partial Knee Arthroplasty surgical procedure

Reason for recall

Certain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking

Distribution

U.S., Netherlands, Japan, China, India, Korea, and Australia.

Key facts

Status

Ongoing

Initiation date

2023-03-10

Report date

2023-04-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1386-2023