Identity Imprint PS Tibial Tray Size 4: Lot 540287
FDA device recall Z-1591-2024 · posted 2024-04-17 · Open, Classified
Recall details
- Recalling firm
- Conformis, Inc.
- 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.
- Action taken
- 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
- Status
- Open, Classified
- Product code
- JWH
- Quantity affected
- 3 units
- Distribution
- US Nationwide distribution in the states of FL, KS and NH.
- Date initiated
- 2024-03-11
- Date posted
- 2024-04-17
- Location
- Billerica, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRS (K231233) | Conformis, Inc. | 2023-05-26 |
| Identity Imprint Knee Replacement System (K210191) | Conformis, Inc. | 2021-05-06 |