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