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Recall Observatory FDA recall evidence

Device product

SCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm Orthopedic surgical instrument component, for hip surgery

Z-0270-2020

October 02, 2019

Class II

Product summary

Firm
Pega Medical Inc.
Event
Event 84017
Status
Terminated
Classification
Class II
Quantity
31 devices
Official record key
device-enforcement:Z-0270-2020

Official wording

Reason: There is a potential for the screws to have become loosened during ultrasonic cleaning of the knobs and the screws may come out.

Code information: Catalogue Numbers: SCF-KNB265, SCF-KNB273, SCF-KNB365, SCF-KNB373; Lot Numbers: 160428-03, 160428-04, A182-05, A182-15, 160603-05, 160603-06, A183-06

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is a potential for the screws to have become loosened during ultrasonic cleaning of the knobs and the screws may come out.