FDA Device recall Z-2278-2019
SLIM Handle - catalogue #: SLM-HND100 a component of Simple Locking Intramedullary (SLIM) System
- FDA Device
- Class II
- terminated
- Published 2019-08-21
On 2019-08-21 the FDA classified a Class II recall of SLIM Handle - catalogue #: SLM-HND100 a component of Simple Locking Intramedullary (SLIM) System by Pega Medical, citing handle could jam with the Driver due to the detachment of an internal Connector Ring.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2278-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-05-29 |
| Published | 2019-08-21 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Pega Medical |
| Distribution | CA, DE, FL, IL, NC, NE, NY, TN |
Product
SLIM Handle - catalogue #: SLM-HND100 a component of Simple Locking Intramedullary (SLIM) System
Reason
Handle could jam with the Driver due to the detachment of an internal Connector Ring.
Identifiers
| code_info | Lot # 150115-09, 160427-01 and A162-02 |
|---|
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-2278-2019%22
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