Recalls / —

—#155985

Product

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

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) 16HGA0031 b) 16HGA0034 c) 16HGA0035

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 #155985. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.