Reported Jun 7, 2023 · Ongoing
Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Tray, Part Numbers: a) REF 1-10012-100, SIZE 1-LEFT…
Smith & Nephew, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Smith & Nephew, Inc. · 1450 E Brooks Rd · Memphis, TN · 38116-1804
Is this the product you have?
12 of 12 products
| Model / number | Product as published |
|---|---|
1-10012-100 | SIZE 1-LEFT MEDIAL |
1-10012-150 | SIZE 1-RIGHT MEDIAL |
1-10012-200 | SIZE 2-LEFT MEDIAL |
1-10012-250 | SIZE 2-RIGHT MEDIAL |
1-10012-300 | SIZE 3-LEFT MEDIAL |
1-10012-350 | SIZE 3-RIGHT MEDIAL |
1-10012-400 | SIZE 4-LEFT MEDIAL |
1-10012-450 | SIZE 4-RIGHT MEDIAL |
1-10012-500 | SIZE 5-LEFT MEDIAL |
1-10012-550 | SIZE 5-RIGHT MEDIAL |
1-10012-600 | SIZE 6-LEFT MEDIAL |
1-10012-650 | SIZE 6-RIGHT MEDIAL; Unicondylar knee prothesis |
- Amount recalled
- 2146 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Smith & Nephew, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.