Smith & Nephew recalls ENGAGE Cementless Partial Knee Systems with potential higher revision rates than similar devices. Affected models include REF 1-10011-100 to 300. No immediate action needed but monitor for complications.
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 partial knee implants due to higher-than-expected revision rates compared to similar devices. This means some patients might need additional surgery more often than expected. The recall does not require immediate action but ongoing monitoring is advised.
The recall is based on data showing these implants have a higher revision rate than similar devices in global registries. Revision means needing additional surgery to fix the implant. This could lead to more surgeries than expected for some patients.
Patients who received the recalled ENGAGE Cementless Partial Knee System implants are most at risk. The recall applies to specific model numbers and batch ranges sold globally.
Check if your implant has part numbers REF 1-10011-100 (size 1-2), REF 1-10011-200 (size 3-4), or REF 1-10011-300 (size 5-6). All batches of these models are affected.
Contact your surgeon if you experience pain, swelling, or instability in the knee that worsens over time.
No, the recall does not require immediate action. Patients should monitor for signs of revision and contact their surgeon if needed.
The affected models are REF 1-10011-100 (size 1-2), REF 1-10011-200 (size 3-4), and REF 1-10011-300 (size 5-6).
The recall does not include a fix or replacement. Patients should monitor for revision symptoms and contact their surgeon if needed.
We’ve drafted a message you can send Smith & Nephew to request your refund or repair — edit it as you like.
Subject: Recall Z-1671-2023 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-1671-2023 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.
