FDAClass IIDecember 4, 2013

Synthes Spiked Washers 13.5/6.5 Spiked Washers 13.5/6.5 recall: Labeling Error

Synthes Spiked Washers 13.5/6.5 Spiked Washers 13.5/6.5 are intended to be used in ligament reattachment or fixation, specifically readaptation of…

Why was Synthes Spiked Washers 13.5/6.5 Spiked Washers 13.5/6.5 recalled?

During a retrospective assessment, Spiked Washers 13.5/6.5 were discovered to be mislabeled as Spiked Washers 13.5/5.5.

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?

part 219.951 with multiple lot#: 2335941 2339634 2397429 2405812 2440475 2442736 2496414 5661855 5663841

Product
Synthes Spiked Washers 13.5/6.5 Spiked Washers 13.5/6.5 are intended to be used in ligament reattachment or fixation, specifically readaptation of…
Recalling firm
Synthes USA HQ, Inc.
Quantity
3087
Distribution
Nationwide Distribution
Recall date
December 4, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
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