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Recall Observatory FDA recall evidence

Device 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

Z-2625-2017

May 30, 2017

Class II

Product summary

Firm
Smith & Nephew, Inc.
Event
Event 77413
Status
Terminated
Classification
Class II
Quantity
46 units
Official record key
device-enforcement:Z-2625-2017

Official wording

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

Code information: Lot numbers: a) 16HGA0040 b) 16JGA0003 c) 16JGA0005 d) 16JGA0006 e) 16JGA0007

Distribution pattern: US distribution to TN

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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