FDAClass IIDecember 4, 2013

Synthes Implant Holder for Synfix recall

Synthes Implant Holder for Synfix (TM)-LR the Synthes Implant Holder for Synfix (TM)-LR is a non-powered hand-held device intended for medical…

Why was Synthes Implant Holder for Synfix recalled?

Complaints were received which described the SynFix LR implant holder breaking at the interface between the implant and the holder.

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?

all lots of part no. 03.802.039

Product
Synthes Implant Holder for Synfix (TM)-LR the Synthes Implant Holder for Synfix (TM)-LR is a non-powered hand-held device intended for medical…
Recalling firm
Synthes USA HQ, Inc.
Quantity
548
Distribution
Worldwide Distribution - USA (nationwide) and Internationally to Canada .
Recall date
December 4, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls