SCFE Driver — Class II medical device recall Z-0324-2016
Terminated recall by Pega Medical Inc., reported 2015-12-02, distributed in FL, TN. SCFE Driver's threaded shaft broke close to the knob when a manual force was applied during the fixation of th
| Recall number | Z-0324-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pega Medical Inc., Laval, N/A, Canada |
| Recall initiated | 2015-10-20 |
| Classified | 2015-11-20 |
| Reported by FDA | 2015-12-02 |
| Terminated | 2016-08-16 |
| Distributed | FL, TN |
| Quantity | 4 units |
| Lot numbers | 130703-01, 130703-02 |
| Model numbers | SCF-MLD265, SCF-MLD273 |
Product
SCFE Driver (SCF-MLD273 & SCF-MLD265) instrument used for the insertion of the Free Gliding SCFE Screw System. This instrument is included in the Free Gliding SCFE Screw System instrument tray. This instrument is marked with the catalogue number and lot number. The Free-Gliding SCFE Screw System is a temporary implant for stabilization of pediatric femoral neck fractures and slipped capital femoral epiphysis (SCFE) in pediatric patients. Orthopedic.
Reason for recall
SCFE Driver's threaded shaft broke close to the knob when a manual force was applied during the fixation of the screw.
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-0324-2016. 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.