Smith&Nephew ENGAGE Cementless Partial Knee System, Tibial Anchor Stem, Part Numbers: a) REF 1-...
FDA Recall #Z-1671-2023 — Class II — May 2, 2023
Product Description
Smith&Nephew ENGAGE Cementless Partial Knee System, Tibial Anchor Stem, Part Numbers: a) REF 1-10011-100 (SIZE 1-2), b) REF 1-10011-200 (SIZE 3-4), c) REF 1-10011-300 (SIZE 5-6); Unicondylar knee prothesis
Reason for Recall
Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential signal that the performance is an outlier versus the state of the art with respect to the risk for revision.
Recalling Firm
Smith & Nephew, Inc. — Memphis, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
1596 units
Distribution
US Nationwide distribution.
Code Information
a) REF 1-10011-100, UDI/DI 00885556873083; b) REF 1-10011-200, UDI/DI 00885556873090; c) REF 1-10011-300, UDI/DI 00885556873106; ALL BATCHES
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated