RecallRadar

FDA Device recall Z-2625-2017

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) R…

On 2017-07-05 the FDA classified a Class II recall of 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) R… by Smith And Nephew, citing the incorrect Loctite adhesive was used to assemble the impactor heads.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2625-2017
ClassificationClass II
Statusterminated
Initiated2017-05-30
Published2017-07-05
Last updated2026-09-13 11:54 UTC
CompanySmith And Nephew
DistributionTN

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

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

Identifiers

code_infoLot numbers: a) 16HGA0040 b) 16JGA0003 c) 16JGA0005 d) 16JGA0006 e) 16JGA0007

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2625-2017%22

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