FDA recall Z-0097-2018

Smith & Nephew, Inc. · Class II · device

Product

smith&nephew TRIGEN INTERTAN 10S, REF 71675384, 10 MM X 18 CM NAIL, 130o (degrees), SET SCREW PREASSEMBLED IN NAIL

Reason for recall

A single lot of INTERTAN 10S 10 MM X 18 CM 130 D was manufactured with the screw inserted upside down.

Distribution

US Distribution - TN, IL, CT, MO, CA., and Internationally to Italy and Germany

Key facts

Status
Ongoing
Initiation date
2017-10-24
Report date
2017-11-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
Memphis, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0097-2018