SLIM Handle — Class II medical device recall Z-2278-2019
Terminated recall by Pega Medical Inc., reported 2019-08-21, distributed in CA, DE, FL, IL, NC, NE, NY, TN. Handle could jam with the Driver due to the detachment of an internal Connector Ring.
| Recall number | Z-2278-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pega Medical Inc., Laval, N/A, Canada |
| Recall initiated | 2019-05-29 |
| Classified | 2019-08-14 |
| Reported by FDA | 2019-08-21 |
| Terminated | 2021-01-15 |
| Distributed | CA, DE, FL, IL, NC, NE, NY, TN |
| Quantity | 19 |
| Reason classes | device malfunction |
| Lot numbers | 150115-09, 160427-01, A162-02 |
| Model numbers | SLM-HND100 |
Product
SLIM Handle - catalogue #: SLM-HND100 a component of Simple Locking Intramedullary (SLIM) System
Reason for recall
Handle could jam with the Driver due to the detachment of an internal Connector Ring.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2278-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.