Recall Z-0324-2016— Pega Medical Inc.
Class II · Terminated
Class II FDA medical device recall by Pega Medical Inc., initiated 2015-10-20, terminated 2016-08-16. It names one FDA 510(k) clearance: K131591. Product: 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.. Reason: SCFE Driver's threaded shaft broke close to the knob when a manual force was applied during the fixation of the screw..
- Recalling firm
- Pega Medical Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-10-20
- Terminated
- 2016-08-16
- Firm location
- Laval, N/A, Canada
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
SCFE Driver's threaded shaft broke close to the knob when a manual force was applied during the fixation of the screw.
Data sourced from openFDA. This site is unofficial and independent of the FDA.