SCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm Orthopedic surgical instrument component, for hip surgery
Reported: November 13, 2019 Initiated: October 2, 2019 #Z-0270-2020
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.
Details
- Recalling Firm
- Pega Medical Inc.
- Units Affected
- 31 devices
- Distribution
- Nationwide distribution to CA, FL, GA, HI, LA, MA, MO, NC, NY, OK. International distribution to AUSTRALIA, CANADA, DENMARK, GERMANY, ISRAEL, MEXICO, ROMANIA, RUSSIA, UNITED ARAB EMIRATES, UNITED KINGDOM
- Location
- Laval, N/A
Frequently Asked Questions
What product was recalled? ▼
SCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm Orthopedic surgical instrument component, for hip surgery. Recalled by Pega Medical Inc.. Units affected: 31 devices.
Why was this product recalled? ▼
There is a potential for the screws to have become loosened during ultrasonic cleaning of the knobs and the screws may come out.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 13, 2019. Severity: Moderate. Recall number: Z-0270-2020.
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