FDAClass IIJuly 8, 2015

Slipped Capital Femoral Epiphysis recall

Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Screw System with catalogue number SCF-MLD265 and SCF-MLD273.

Why was Slipped Capital Femoral Epiphysis 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Part Number: SCF-MLD265, LOT#: 130703-01. Part Number: SCF-MLD273, LOT#: 130703-02.

Product
Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Screw System with catalogue number SCF-MLD265 and SCF-MLD273.
Recalling firm
Pega Medical Inc.
Quantity
4 units
Distribution
US Distribution to the states of : FL and TN.
Recall date
July 8, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls