—#155986

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

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K162775
Affected lot / code info: Lot numbers: a) 16HGA0040 b) 16JGA0003 c) 16JGA0005 d) 16JGA0006 e) 16JGA0007

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Smith & Nephew, Inc.
Address: 1450 E Brooks Rd, Memphis, Tennessee 38116-1804

Distribution

Distribution pattern: US distribution to TN

Timeline

Recall initiated: 2017-05-30
Posted by FDA: 2017-06-12
Terminated: 2021-12-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #155986. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.