FDA-Device2019-11-13Class II
SCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm Orthopedic surgical instrument component, for hip surgery
Pega Medical Inc.
Hazard
There is a potential for the screws to have become loosened during ultrasonic cleaning of the knobs and the screws may come out.
Sold states
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
Affected count
31 devices
Manufactured in
1111 Chomedey (A-13) E, N/A, Laval, N/A, Canada
Products
SCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm Orthopedic surgical instrument component, for hip surgery
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0270-2020Don't want to check this manually?
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