Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-1671-2023

May 02, 2023

Class II

Product summary

Firm
Smith & Nephew, Inc.
Event
Event 92286
Status
Ongoing
Classification
Class II
Quantity
1596 units
Official record key
device-enforcement:Z-1671-2023

Official wording

Reason: 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.

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

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.