Slipped Capital Femoral Epiphysis — Class II medical device recall Z-1848-2015
Terminated recall by Pega Medical Inc., reported 2015-07-08, distributed in FL, TN. SCFE Drivers of the Free-Gliding SCFE Screw System are recalled because the handle of the instruments may deta
| Recall number | Z-1848-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pega Medical Inc., Laval, Canada |
| Recall initiated | 2015-06-15 |
| Classified | 2015-06-26 |
| Reported by FDA | 2015-07-08 |
| Terminated | 2015-12-29 |
| Distributed | FL, TN |
| Quantity | 4 units |
| Reason classes | device malfunction |
| Lot numbers | 130703-01, 130703-02 |
| Model numbers | SCF-MLD265, SCF-MLD273 |
Product
Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Screw System with catalogue number SCF-MLD265 and SCF-MLD273.
Reason for recall
SCFE Drivers of the Free-Gliding SCFE Screw System are recalled because the handle of the instruments may detach from the shaft if high torques are applied in counter-clockwise rotation.
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-1848-2015. 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.