Reported Dec 2, 2015 · Terminated
SCFE Driver (SCF-MLD273 & SCF-MLD265) instrument used for the insertion of the Free Gliding SCFE Screw System. This…
Pega Medical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Pega Medical Inc. · 1111 Autoroute Chomedy · Laval, N/A · N/A
Is this the product you have?
- 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.
- Lot codes and dates
- Part Number
SCF-MLD265LOT#: 130703-01
- Part Number
SCF-MLD273LOT#: 130703-02
- Part Number
- Amount recalled
- 4 units distributed in the US
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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