Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
SCFE Driver (SCF-MLD273 & SCF-MLD265) instrument used for the insertion Recalled by Pega Medical Inc. Due to SCFE Driver's threaded shaft broke close to the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Pega Medical Inc. directly.
Affected Products
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.
Quantity: 4 units distributed in the US
Why Was This Recalled?
SCFE Driver's threaded shaft broke close to the knob when a manual force was applied during the fixation of the screw.
Where Was This Sold?
This product was distributed to 2 states: FL, TN
About Pega Medical Inc.
Pega Medical Inc. has 9 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report