Slipped Capital Femoral Epiphysis (SCFE) Drivers of the… recallZ-1848-2015 · Pega Medical Inc. · initiated Jun 15, 2015
Class II Terminated All recalls posted in June 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 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.
FDA root cause category: Reprocessing Controls
What the company is doing
Pega Medical sent an Urgent Field Safety-Recall letter via email on June 15, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Advise on action to be taken by the customer: Identify the device with the same catalogue number and lot number Return the device to Pega Medical Inc. to the address shown below using the FedEx account. For further questions please call the firm at 450-688-5144 x. 242.
Recall details
- Recall number
- Z-1848-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jun 15, 2015
- Posted by the FDA
- Jun 26, 2015
- Recalling firm
- Pega Medical Inc.
- Quantity
- 4 units
- Product code
- HWC
- FDA submissions
- K131591
- Distribution
- US Distribution to the states of : FL and TN.
Product description
Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Screw System with catalogue number SCF-MLD265 and SCF-MLD273.
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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