Recall Z-0270-2020— Pega Medical Inc.
Class II · Terminated
Class II FDA medical device recall by Pega Medical Inc., initiated 2019-10-02, terminated 2020-10-26. FDA's recall record names no specific 510(k) clearance for this event. Product: SCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm Orthopedic surgical instrument component, for hip surgery. Reason: There is a potential for the screws to have become loosened during ultrasonic cleaning of the knobs and the screws may come out..
- Recalling firm
- Pega Medical Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-10-02
- Terminated
- 2020-10-26
- Firm location
- Laval, N/A, Canada
Product description
SCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm Orthopedic surgical instrument component, for hip surgery
Reason for recall
There is a potential for the screws to have become loosened during ultrasonic cleaning of the knobs and the screws may come out.
Data sourced from openFDA. This site is unofficial and independent of the FDA.