stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in a Partial Knee Arthroplasty surgical procedure
Reported: April 19, 2023 Initiated: March 10, 2023 #Z-1386-2023
Product Description
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
Details
- Recalling Firm
- Howmedica Osteonics Corp.
- Units Affected
- 102 units
- Distribution
- U.S., Netherlands, Japan, China, India, Korea, and Australia.
- Location
- Mahwah, NJ
Frequently Asked Questions
What product was recalled? ▼
stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in a Partial Knee Arthroplasty surgical procedure. Recalled by Howmedica Osteonics Corp.. Units affected: 102 units.
Why was this product recalled? ▼
Certain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 19, 2023. Severity: Moderate. Recall number: Z-1386-2023.
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