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Pega Medical Inc. recalls SCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm Orthopedic surgical instrument component, f
Recalled November 13, 2019 · FDA recall Z-0270-2020 · Pega Medical
Hazard
There is a potential for the screws to have become loosened during ultrasonic cleaning of the knobs and the screws may come out. · FDA Class II
Units
31 devices
Sold at
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
Description
There is a potential for the screws to have become loosened during ultrasonic cleaning of the knobs and the screws may come out.
Product
SCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm Orthopedic surgical instrument component, for hip surgery
Manufacturer(s)
Pega Medical Inc.
Made in
Canada
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →