FDA-Device2017-07-05Class II

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

Hazard

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

Sold states
US distribution to TN
Affected count
46 units
Manufactured in
1450 E Brooks Rd, N/A, Memphis, TN, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2625-2017

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