FDAClass IIMarch 2, 2016

Stryker recall

Stryker, T2 Fixation K-Wire 3 x 285mm WCH coated Product Usage: Intended for the temporary stabilization of bone segments or fragments.

Why was Stryker recalled?

During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.

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?

Catalog number 1806-1417S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life

Product
Stryker, T2 Fixation K-Wire 3 x 285mm WCH coated Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Recalling firm
Stryker Howmedica Osteonics Corp.
Quantity
147,838 units in total
Distribution
US Nationwide Distribution
Recall date
March 2, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
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