PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610
FDA device recall Z-0524-2024 · posted 2023-12-09 · Open, Classified
Recall details
- Recalling firm
- Limacorporate S.p.A
- Reason for recall
- Due to incorrect product labeling
- Action taken
- On 10/27/2023, the firm sent via email an "URGENT: MEDICAL DEVICE RECALL" Letter to customer informing them that the firm was made aware of a mistake on the label of the HPS tibial liner #6H. 10mm. Customers are instructed to: Check their stock to locate and quarantine the affected devices. Devices must be sent back to the Lima local reference within 15 days together with a hard copy of the attached Acknowledgement and Receipt Form at the following address: Lima U.S.A., Inc. | 2001 NE Green Oaks Blvd. Ste.100 | Arlington, Texas 76006 | USA For questions or further assistance, email medicalcomplaints@limacorporate.com.
- Root cause
- Labeling Change Control
- Status
- Open, Classified
- Product code
- JWH
- Quantity affected
- 33 devices
- Distribution
- U.S Distribution: AZ, CA, IL, LA, and NY
- Date initiated
- 2023-10-27
- Date posted
- 2023-12-09
- Location
- San Daniele Del Friuli, Italy
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Physica system (K213381) | Lima Corporate S.P.A. | 2021-12-17 |