FDA-Device2017-07-05Class II

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

Smith & Nephew, Inc.
Hazard

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

Sold states
US distribution to TN
Affected count
36 units
Manufactured in
1450 E Brooks Rd, N/A, Memphis, TN, United States
Products
LEGION(R) FEM CONE IMPACTOR HEADS: a) REF 71441976, ID 18MM b) REF 71441977, ID 20MM c) REF 71441978, ID 22MM

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2624-2017

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