FDA Device recall Z-2038-2020
Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medullary (SLIM) System - Product Usage: The SLIM handle is the grip…
- FDA Device
- Class III
- terminated
- Published 2020-05-27
On 2020-05-27 the FDA classified a Class III recall of Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medullary (SLIM) System - Product Usage: The SLIM handle is the grip… by Pega Medical, citing the lot number on the pediatric orthopedic implant driver instrument handle does not match the lot number on the label.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2038-2020 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2020-04-03 |
| Published | 2020-05-27 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Pega Medical |
| Distribution | US |
Product
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.
Reason
The lot number on the pediatric orthopedic implant driver instrument handle does not match the lot number on the label.
Identifiers
| code_info | SLIM Handle with Catalog #SLM-HND100 with etched lot code #B204-1 on the handle and with Lot# B204-01 on the packaging label. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2038-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.