Conformis recalls a limited number of iTotal PS knee replacement systems with incorrect serial numbers delivered to the wrong customers. This does not pose a safety risk but requires correction of labeling.
A limited number of tibial trays were labeled with an incorrect serial number and were delivered to the wrong customer accounts.
Conformis is recalling a specific model of knee replacement system due to incorrect serial numbers being assigned to the wrong customers. This issue does not affect the safety of the product but requires correction of the labeling to ensure proper tracking.
The incorrect serial numbers were delivered to the wrong customer accounts, which could lead to mislabeling of the implant kit. This does not cause harm during use but may result in incorrect tracking and potential confusion in the surgical process.
Patients who received the iTotal PS Knee Replacement System with the model number TPS-111-1111-010101 and were labeled with an incorrect serial number. Surgeons and medical staff involved in the implant process are most at risk of mislabeling.
Check for the model number TPS-111-1111-010101 on the iTotal PS Knee Replacement System (left side). The product was delivered to the wrong customer accounts due to an incorrect serial number label.
Check the model number on the product to confirm it is TPS-111-1111-010101.
No, the recall is for labeling errors, not a safety hazard. The product is safe to use but requires correction of the serial number label.
Look for the model number TPS-111-1111-010101 on the iTotal PS Knee Replacement System (left side).
Verify the product label to confirm it matches the model number TPS-111-1111-010101. No action is needed beyond this check.
We’ve drafted a message you can send Conformis to request your refund or repair — edit it as you like.
Subject: Recall Z-1628-2020 — Conformis Conformis Hello, I own a Conformis that is covered by recall Z-1628-2020 from Conformis. 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.
