Identity Imprint PS Tibial Tray Size 4: Lot 540287
FDA Recall Z-1591-2024 · Posted 2024-04-17
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Recalling FirmConformis, Inc.
Recall StatusOpen, Classified
Product CodeJWH
Date Initiated2024-03-11
Product Quantity3 units
Reason for Recall
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.
Firm Action
On March 22, 2024 customers were sent URGENT MEDICAL DEVICE FIELD ACTION letters via email. Customers were provided the following instructions: Conformis is seeking the return of the devices in boxes marked with Lot 508287 or Lot 540827. This is the only lot that was distributed. Our records indicate you are the recipient of one of the affected Lot. If you have not already, please return the device using the provided FEDEX label. Additionally, return page 2 of this letter to acknowledge receipt of this notification. Please read, complete, and sign page 2 of this letter. If you have any questions please contact myself or another Conformis representative. If you have an urgent question, please call customer service 781 345 9001.
Root Cause
Process design
Distribution Pattern
US Nationwide distribution in the states of FL, KS and NH.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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