Z-1385-2023 Class II Ongoing
FDA device recall Z-1385-2023 was initiated by Howmedica Osteonics Corp. on March 10, 2023 and is designated Class II. Reason for recall: Ccertain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking The recall status is ongoing. Affected quantity: 52 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 19, 2023
- Initiation Date
- March 10, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 52 units
Product Description
stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intended for use in a Partial Knee Arthroplasty surgical procedure
Reason for Recall
Ccertain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking
Distribution Pattern
U.S., Netherlands, Japan, China, India, Korea, and Australia.
Code Information
GTIN 00848486003746, Lot Number 26270421