Corin recalls Unity Total Knee System model 112.001.34 with batch numbers 529803-532405 due to potential incorrect labeling of knee implant sizes.
Potential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labelled as Unity CR Inserts Right size 7 from batch 532405 and visa versa.
Corin is recalling a specific model of total knee replacement implants because some units may have the wrong size label. This could lead to improper fitting during surgery, which might cause complications for patients.
The recall involves a labeling error where size 6 implants might be labeled as size 7 and vice versa. This could result in the wrong implant size being used during surgery, potentially causing improper joint function or complications.
Patients who received the Unity Total Knee System model 112.001.34 with batch numbers 529803 to 532405 are affected. Surgeons and medical facilities using these implants are at risk of administering incorrect sizes during procedures.
Check for the model number 112.001.34 on the implant packaging. Look for batch numbers 529803 through 532405 on the implant's documentation or label.
Verify the batch number on the implant's documentation to confirm it is not in the range 529803 to 532405.
The recall is due to a potential labeling error where size 6 implants may be incorrectly labeled as size 7 and vice versa, which could lead to improper implant fitting during surgery.
Check the batch number on the implant documentation. If it falls between 529803 and 532405, contact Corin for guidance.
The recall addresses a labeling error that could lead to improper implant fitting, but the risk of serious injury is low as the issue is specific to labeling and not the implant itself.
We’ve drafted a message you can send Corin to request your refund or repair — edit it as you like.
Subject: Recall Z-0214-2024 — Corin Corin Hello, I own a Corin that is covered by recall Z-0214-2024 from Corin. 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.
