Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Screw System with catalogue number SCF-MLD265 and SCF-MLD273.
FDA Recall Z-1848-2015 · Posted 2015-06-26
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Recalling FirmPega Medical Inc.
Recall StatusTerminated
Product CodeHWC
Date Initiated2015-06-15
Date Terminated2015-12-29
Product Quantity4 units
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.
Firm Action
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.
Root Cause
Reprocessing Controls
Distribution Pattern
US Distribution to the states of : FL and TN.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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