FDAClass IIJune 12, 2019

Lineum 4.35mm x 28mm Translation Screw recall

Lineum 4.35mm x 28mm Translation Screw, Model No. 14-524728 The Lineum OCT Spine System is intended to provide immobilization and stabilization of…

Why was Lineum 4.35mm x 28mm Translation Screw recalled?

Etching on the tulip head incorrectly states "24MM" instead of the correct "28MM" marking.

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 M26888

Product
Lineum 4.35mm x 28mm Translation Screw, Model No. 14-524728 The Lineum OCT Spine System is intended to provide immobilization and stabilization of…
Recalling firm
Zimmer Biomet, Inc.
Quantity
64
Distribution
US Distribution to CA, NC, and NY; and International to Germany.
Recall date
June 12, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
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