FDA recall Z-2625-2017

Smith & Nephew, Inc. · Class II · device

Product

LEGION(R) TIB CONE IMPACTOR HEADS: a) REF 71441972, ID 24MM b) REF 71441971, ID 22MM c) REF 71441973, ID 26MM d) REF 71441974, ID 28MM e) REF 71441975, ID 30MM

Reason for recall

The incorrect Loctite adhesive was used to assemble the impactor heads.

Distribution

US distribution to TN

Key facts

Status
Terminated
Initiation date
2017-05-30
Report date
2017-07-05
Termination date
2021-12-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Memphis, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2625-2017