FDAClass IIJuly 5, 2017

Legion(r) TIB Cone Impactor Heads: A) recall

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…

Why was Legion(r) TIB Cone Impactor Heads: A) recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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…
Recalling firm
Smith & Nephew, Inc.
Quantity
46 units
Distribution
US distribution to TN
Recall date
July 5, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
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