FDA recall Z-2945-2020

Smith & Nephew, Inc. · Class II · device

Product

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

International Distribution to the countries of Denmark, Sweden, France and Spain.

Key facts

Status
Terminated
Initiation date
2020-08-24
Report date
2020-09-16
Termination date
2022-07-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Memphis, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2945-2020