Z-0270-2020 Class II Terminated
FDA device recall Z-0270-2020 was initiated by Pega Medical Inc. on October 2, 2019 and is designated Class II. 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. The recall status is terminated (terminated October 26, 2020). Affected quantity: 31 devices.
Recall Details
- Product Type
- Devices
- Report Date
- November 13, 2019
- Initiation Date
- October 2, 2019
- Termination Date
- October 26, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 31 devices
Product Description
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 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
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