Z-2945-2020 Class II Terminated
FDA device recall Z-2945-2020 was initiated by Smith & Nephew, Inc. on August 24, 2020 and is designated Class II. Reason for recall: Multiple or incorrect expiration dates were provided on the affected designation labels. The recall status is terminated (terminated July 11, 2022). Affected quantity: 71 units.
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.