Recall Z-2038-2020 ยท LXH Orthopedic Manual Surgical Instrument
Pega Medical Inc.
Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medullary (SLIM) System - Product Usage: The SLIM handle is the grip for the SLIM driver in orthopedic surgical procedures.
| Date | Apr 3, 2020 |
| Status | Terminated |
| Reason | The lot number on the pediatric orthopedic implant driver instrument handle does not match the lot number on the label. |
| Root cause | Nonconforming Material/Component |
| Action | On 04/03/2020 Pega Medical Inc. sent out an email which included a Field Safety Notice letter to their US consignee identifying the problem, the actions to be taken by the customer/user in order to prevent risks for patients/users, and the actions planned by Pega Medical Inc. to correct the problem. PRODUCTS: The Handle of the Driver of the Simple Locking intramedullary System (SLIM) WITH CATALOG # SLM-HND100 which was distributed to the identified US consignee on 12/24/2019, with lot #8204-1 marked on the part (the driver handle) and with packaging labeled with lot# 8204-01. ACTION TO BE TAKE |
| Quantity | 3 units |
| Distribution | US Nationwide Distribution including in the states of Florida. No Foreign Consignees listed. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.