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Terminated

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

FDA Recall Z-2624-2017 · Posted 2017-06-12

Recalling FirmSmith & Nephew, Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2017-05-30
Date Terminated2021-12-10
Product Quantity36 units

Reason for Recall

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

Firm Action

The firm notified the consignee by email on 05/30/2017. The notice directed the consignee to inspect its inventory and locate any unused devices from the listed product and batch numbers, and quarantine them immediately. Distributors were directed to notify their customers of the field action and ensure the recall directions were followed.

Root Cause

Process control

Distribution Pattern

US distribution to TN

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K162775Legion Cone SystemSmith & Nephew, Inc. · 2017-01-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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