Smith & Nephew recalls certain ENGAGE Cementless Partial Knee Systems due to potential higher revision rates than similar devices in global registries. Affected parts include specific sizes and part numbers.
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 specific models of cementless partial knee implants because recent data shows these implants may have a higher revision rate compared to similar devices in global registries. This could mean the implants might need to be replaced more often than expected.
The recall is based on data showing that these implants may have a higher revision rate than similar devices in global joint replacement registries. Revision means the implant needs to be removed and replaced, which can happen more frequently than expected.
Patients who received one of the recalled knee implants during surgery are likely affected. Those with the specific part numbers listed in the recall are at the highest risk.
Check if your implant has part numbers starting with REF 1-10012 followed by a size (e.g., 100, 150, 200) and is labeled as LEFT or RIGHT MEDIAL. The recall covers all batches of these specific implants.
Review your implant's part number and size to see if it matches the recalled models listed in the notice.
Recent data shows these implants may have a higher revision rate than similar devices in global registries, meaning they might need to be replaced more often.
Yes, you should check your implant details to see if it matches the recalled models. If it does, contact Smith & Nephew for further instructions.
The recall covers specific part numbers and sizes listed in the notice. Not all versions of the implant are affected.
We’ve drafted a message you can send Smith & Nephew to request your refund or repair — edit it as you like.
Subject: Recall Z-1672-2023 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-1672-2023 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.
