FDA Device

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

Hazard

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

What You Should Do

Remedy

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.

Products

LEGION(R) FEM CONE IMPACTOR HEADS: a) REF 71441976, ID 18MM b) REF 71441977, ID 20MM c) REF 71441978, ID 22MM
Brand
Smith & Nephew, Inc.
UPC
Lot numbers: a) 16HGA0031 b) 16HGA0034 c) 16HGA0035

Units Affected

36 units