Recall Z-0524-2024 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Limacorporate S.p.A
PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610
| Date | Dec 9, 2023 (initiated Oct 27, 2023) |
| Status | Open, Classified |
| Reason | Due to incorrect product labeling |
| Root cause | Labeling Change Control |
| Action | 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 medicalco |
| Quantity | 33 devices |
| Distribution | U.S Distribution: AZ, CA, IL, LA, and NY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K213381 | Physica system Lima Corporate S.P.A., Dec 17, 2021 |