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
Reported: June 7, 2023 Initiated: May 2, 2023 #Z-1671-2023
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.
Details
- Recalling Firm
- Smith & Nephew, Inc.
- Units Affected
- 1596 units
- Distribution
- US Nationwide distribution.
- Location
- Memphis, TN
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Smith & Nephew, Inc.. Units affected: 1596 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 7, 2023. Severity: Moderate. Recall number: Z-1671-2023.
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