Z-1671-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- June 7, 2023
- Initiation Date
- May 2, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1596 units
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.
Distribution Pattern
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