Encore Medical recalls knee tibial inserts with incorrect size labeling that could lead to surgical delays or wrong pin sizes during surgery. Affected products include specific sizes and reference numbers.
Tibial insert implant large boxes were labeled small and the small boxes were labeled large. If the incorrect labeling is identified this could lead to surgical delay and if the surgeon does not recognize the size discrepancy between the insert label and the pin label, the surgeon may implant the incorrect pin size.
Encore Medical is recalling knee tibial inserts that have incorrect size labels. If the wrong size is used during surgery, it could cause delays or the surgeon might implant the wrong pin size.
The tibial inserts come in boxes labeled with the wrong size (large boxes labeled small, small boxes labeled large). If the surgeon doesn't notice the size discrepancy between the insert label and pin label, they might implant the incorrect pin size, causing surgical delays or complications.
Patients who have received these specific knee tibial inserts for surgery are affected. Surgeons who use the products without verifying the size labels are at higher risk.
Check for the product names and reference numbers listed in the recall: EMPOWR VVC KNEE TIBIAL INSERT, sizes 2-11, with reference numbers like 346-22-706 to 346-25-766. The specific lot numbers and UDI-DI codes are also listed in the recall.
Look for the reference numbers and size labels on the product to confirm if it matches the recalled items.
The recall is happening because the tibial inserts have incorrect size labels that could lead to surgical delays or the surgeon might implant the wrong pin size if the size discrepancy isn't noticed.
The recall does not include a specific remedy, so check the product labels to see if it matches the recalled items. If you have the product, contact Encore Medical for further instructions.
The recall states that incorrect labeling could lead to surgical delays or wrong pin sizes, but there is no mention of serious injury risks. The danger level is low_risk.
We’ve drafted a message you can send Encore Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1187-2023 — Encore Medical Encore Medical Hello, I own a Encore Medical that is covered by recall Z-1187-2023 from Encore Medical. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
