United Orthopedic Corporation recalls U2 Total Knee System Tibial Insert due to packaging mismatch with product labeling. Affected units may have incorrect contents.
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 due to a mismatch between the contents in the package and the product labeling. This could lead to confusion about the correct medical device being used.
The recall is based on a report that the contents of the package do not match the product labeling. This mismatch could cause confusion about which implant is being used, potentially leading to incorrect medical procedures.
Patients who received the U2 Total Knee System Tibial Insert with lot number 17B621AX are likely affected. Surgeons and medical staff using this specific implant are at highest risk.
Check for the product name 'U2 Total Knee System Tibial Insert, Posterior Stabilized, #3, 11mm Thick' and catalogue number 2303-3032. The affected lot number is 17B621AX.
Verify that the contents match the product labeling to ensure the correct implant is being used.
The recall is due to a report that the contents of the package do not match the product labeling.
The affected product is the U2 Total Knee System Tibial Insert, Posterior Stabilized, #3, 11mm Thick with catalogue number 2303-3032.
Check for the product name and catalogue number 2303-3032, and verify the lot number is 17B621AX.
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-1128-2018 — United Orthopedic Corporation United Orthopedic Corporation Hello, I own a United Orthopedic Corporation that is covered by recall Z-1128-2018 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.
