Smith & Nephew recalls specific models of cementless partial knee implants due to higher revision rates than similar devices in global registries. Affected parts include coated tibial inserts with part numbers starting REF 1-10013.
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.
Smith & Nephew is recalling certain cementless partial knee implants that may have a higher revision rate than similar devices. This means the implants could become loose or require reoperation more often than expected.
The recall is based on data showing these implants have a higher revision rate than comparable devices in global joint replacement registries. Revision means the implant needs to be removed and replaced, which can cause additional pain and recovery time.
Patients who received the recalled Smith & Nephew ENGAGE Cementless Partial Knee System implants, particularly those with the specific coated tibial inserts listed in the recall. Patients with knee replacements are most at risk.
Check if your knee implant has part numbers starting with REF 1-10013 (e.g., REF 1-10013-109) and the size and side listed (e.g., SIZE 1-LEFT MED). The recall includes specific sizes and right/left sides for all sizes from 1 to 6.
Look for part numbers starting with REF 1-10013 on your implant's packaging or label to confirm if it's affected.
The recall is based on recent data showing these implants have a higher revision rate than similar devices in global joint replacement registries.
The recall does not require replacement; it's a monitoring action to check if your implant needs revision.
Check if your implant has part numbers starting with REF 1-10013 (e.g., REF 1-10013-109) and the size and side listed in the recall notice.
We’ve drafted a message you can send Smith & Nephew to request your refund or repair — edit it as you like.
Subject: Recall Z-1673-2023 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-1673-2023 from Smith & Nephew. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
