Z-2945-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 16, 2020
- Initiation Date
- August 24, 2020
- Termination Date
- July 11, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 71 units
Product Description
EVOS Screws - Product Usage: is a part of the EVOS MINI plating system, indicated for fracture fixation, arthrodesis, reconstruction, replantation or reduction of small bones and small bone fragments.
Reason for Recall
Multiple or incorrect expiration dates were provided on the affected designation labels.
Distribution Pattern
International Distribution to the countries of Denmark, Sweden, France and Spain.
Code Information
Part Numbers: 72424030, 72424010, 72424012, 72424016, 72424018, 72424020, 72424022, 72424024, 72434026, 72434028, 72434030, 72423014, 72423016, 72434065, 72434070, 72434075, 72412465, 72424032, 72424040, 72424055, 72424075, 72424080, 72423044. Batch/Lots: 14FM17199R, 14FM01226R, 14FM01227R, 14FM02610R, 14FM03418R, 14FM03420R, 14FM03422R, 14FM03424R, 14FM13578R, 14FM13580R, 14FM13581R, 14FM15166R, 14FM15167R, 14FM16225R, 14FM16228R, 14FM16229R, 14FM16386R, 14FM17201R, 14FM18527R, 14FM19218R, 14FM19226R, 14FM19229R, 14FM19360R.