Smith&Nephew ENGAGE Cementless Partial Knee System, Tibial Anchor Stem, Part Numbers: a) REF 1-10011-100 (SIZE 1-2), b
Summary
The FDA issued a Class II for Smith&Nephew ENGAGE Cementless Partial Knee System, Tibial Anchor Stem, Part Num by Smith & Nephew, Inc.. Reason: Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registrie.
Details
Source
Device Recall
External ID
Z-1671-2023
Action Date
2023-06-07
Status
Ongoing
Category
device
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
Lot/Code Info: 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
Quantity Affected: 1596 units
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
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-05-02
Company
Memphis, TN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 137 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Smith & Nephew, Inc. has 78 FDA actions in our database, including 34 recalls and 44 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Smith & Nephew, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Smith & Nephew, Inc. have FDA actions?
Smith & Nephew, Inc. has 78 FDA actions in our database, including 34 recalls and 44 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1671-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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