RecallRadar

FDA Device recall Z-2624-2017

LEGION(R) FEM CONE IMPACTOR HEADS: a) REF 71441976, ID 18MM b) REF 71441977, ID 20MM c) REF 71441978, ID 22MM

On 2017-07-05 the FDA classified a Class II recall of LEGION(R) FEM CONE IMPACTOR HEADS: a) REF 71441976, ID 18MM b) REF 71441977, ID 20MM c) REF 71441978, ID 22MM 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-2624-2017
ClassificationClass II
Statusterminated
Initiated2017-05-30
Published2017-07-05
Last updated2026-09-13 11:54 UTC
CompanySmith And Nephew
DistributionTN

Product

LEGION(R) FEM CONE IMPACTOR HEADS: a) REF 71441976, ID 18MM b) REF 71441977, ID 20MM c) REF 71441978, ID 22MM

Reason

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

Identifiers

code_infoLot numbers: a) 16HGA0031 b) 16HGA0034 c) 16HGA0035

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-2624-2017%22

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