Recall Z-1848-2015— Pega Medical Inc.
Class II · Terminated
Class II FDA medical device recall by Pega Medical Inc., initiated 2015-06-15, terminated 2015-12-29. It names one FDA 510(k) clearance: K131591. Product: Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Screw System with catalogue number SCF-MLD265 and SCF-MLD273.. Reason: 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..
- Recalling firm
- Pega Medical Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-06-15
- Terminated
- 2015-12-29
- Firm location
- Laval, 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
Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Screw System with catalogue number SCF-MLD265 and SCF-MLD273.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.