United Orthopedic Corporation recalls U2 Total Knee Tibial Insert PSA model 21mm thick (catalog 2303-5016) due to packaging mismatch with product labeling. Affected patients should contact for details.
UOC received a customer compliant report from our distributor on October 31, 2017 which stated that contents of the package do not match the product labeling.
United Orthopedic Corporation is recalling a specific knee implant component because the packaging does not match the product labels. This mismatch could lead to incorrect use or safety issues if the wrong part is installed.
The recall is triggered by a packaging mismatch where the contents of the package do not match the product labeling. This could result in the wrong implant being used during surgery, potentially causing incorrect fitting or complications.
Patients who received the U2 Total Knee Tibial Insert PSA model 21mm thick (catalog number 2303-5016) with lot number 17B621AG are affected. Surgeons and medical facilities using this implant are most at risk.
Check for the U2 Total Knee Tibial Insert PSA model 21mm thick with catalog number 2303-5016 and lot number 17B621AG. The product is used in knee surgeries for patients with severe knee pain and disability.
Reach out to United Orthopedic Corporation for specific instructions on how to verify your product and get replacement or correction.
The recall is due to a packaging mismatch where the contents of the package do not match the product labeling, as reported by a distributor on October 31, 2017.
Contact United Orthopedic Corporation directly for details on verification and next steps.
The recall does not specify a direct injury risk; the hazard is a packaging mismatch that could lead to incorrect use.
We’ve drafted a message you can send United Orthopedic Corporation to request your refund or repair — edit it as you like.
Subject: Recall Z-1129-2018 — United Orthopedic Corporation United Orthopedic Corporation Hello, I own a United Orthopedic Corporation that is covered by recall Z-1129-2018 from United Orthopedic Corporation. 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.
