SCFE Driver (SCF-MLD273 & SCF-MLD265) instrument used for… recallZ-0324-2016 · Pega Medical Inc. · initiated Oct 20, 2015
Class II Terminated All recalls posted in November 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Pega Medical Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
SCFE Driver's threaded shaft broke close to the knob when a manual force was applied during the fixation of the screw.
FDA root cause category: Unknown/Undetermined by firm
What the company is doing
The firm sent the Urgent Field Safety Notice-Recalls to US consignees via email. Consignees are advised to return affected devices back to the firm. Customer with questions can contact Enrique Garcia at 450-688-5144 ext. 242 or send email to [email protected]
Recall details
- Recall number
- Z-0324-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Oct 20, 2015
- Posted by the FDA
- Nov 20, 2015
- Recalling firm
- Pega Medical Inc.
- Quantity
- 4 units distributed in the US
- Product code
- HWC
- FDA submissions
- K131591
- Distribution
- Distributed in the states of FL and TN.
Product description
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.
Code information (models, lots, serial numbers)
Part Number: SCF-MLD265; LOT#: 130703-01 Part Number: SCF-MLD273; LOT#: 130703-02
Other devices under the same FDA submission
1 device cleared under K131591 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- FREE GLIDING SCFE SCREW SYSTEM SCF-T65-48S/50LOrthopediatrics Canada ULC · Screw, fixation, bone1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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