Conformis recalls Identity Imprint PS Tibial Tray Size : Lot 540287 due to packaging mix-up between lots 540287 and 508287. This may lead to incorrect product use.
Size 5 Tibial Tray from Lot 508287 was packaged in a Size 4 box from Lot 540287. It was confirmed that Lot 540287 and Lot 508287 were swapped between the pouching and final pack.
Conformis is recalling Identity Imprint PS Tibial Tray Size 4 from Lot 540287 because it was mistakenly packaged with Lot 508287. This mix-up could lead to using the wrong size tray, which might cause improper fitting or function.
The recall involves a packaging mix-up where Lot 540287 was mistakenly packaged with Lot 508287. This means the Size 5 tray was shipped in a Size 4 box, potentially leading to incorrect use of the wrong size tray during surgery.
Orthopedic surgeons and medical professionals who use the Identity Imprint PS Tibial Tray Size 4 for surgical procedures may be affected. Those using the specific lot number 540287 are most at risk.
Check the product's lot number on the box or label. The affected product is Identity Imprint PS Tibial Tray Size 4 with Lot 540287 (Catalog Number: TPS-301-T04S).
Look for the lot number 540287 on the box or label to confirm if the product is affected.
Conformis recalled Identity Imprint PS Tibial Tray Size 4 from Lot 540287 due to a packaging mix-up with Lot 508287, which could lead to using the wrong size tray.
The affected product has Lot number 540287. The correct lot number for the Size 4 tray should be 540287, but it was mistakenly packaged with Lot 508287.
Check the product's lot number on the box or label. The affected product is Identity Imprint PS Tibial Tray Size 4 with Lot 540287 (Catalog Number: TPS-301-T04S).
We’ve drafted a message you can send Conformis to request your refund or repair — edit it as you like.
Subject: Recall Z-1591-2024 — Conformis Conformis Hello, I own a Conformis that is covered by recall Z-1591-2024 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.
