Recall Z-1386-2023— Howmedica Osteonics Corp.
Class II · Ongoing
Class II FDA medical device recall by Howmedica Osteonics Corp., initiated 2023-03-10. It names 2 FDA 510(k) clearances: K090763, K082172. Product: stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in a Partial Knee Arthroplasty surgical procedure. Reason: Certain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking.
- Recalling firm
- Howmedica Osteonics Corp.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-03-10
- Firm location
- Mahwah, NJ, United States
510(k) clearances named in this recall
2 on FDA's record- K090763 — RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEM
- K082172 — MAKO MODULAR KNEE COMPARTMENTAL IMPLANT SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.