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Legion(R) Tib Cone Impactor Heads recallZ-2625-2017 · Smith & Nephew, Inc. · initiated May 30, 2017

Class II Terminated All recalls posted in June 2017

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Smith & Nephew, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Process control

What the company is doing

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.

Recall details

Recall number
Z-2625-2017
Recall class
Class II
Status
Terminated
Initiated by the company
May 30, 2017
Posted by the FDA
Jun 12, 2017
Recalling firm
Smith & Nephew, Inc.
Quantity
46 units
Product code
JWH
FDA submissions
K162775
Distribution
US distribution to TN

Product description

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

Code information (models, lots, serial numbers)

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

Other devices under the same FDA submission

12 devices cleared under K162775 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 77413).

Sources and updates

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