FDA recall Z-0270-2020

Product

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.

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

Key facts

Status

Terminated

Initiation date

2019-10-02

Report date

2019-11-13

Termination date

2020-10-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Laval, N/A, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0270-2020