FDAClass IIJuly 15, 2015

Titanium END CAP with T40 Stardrive Recess recall

TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILS-EX; Synthes Tibial Nail System EX is intended to stabilize…

Why was Titanium END CAP with T40 Stardrive Recess recalled?

A specific part and lot number was packaged and shipped prior to the completion of a required internal inspection.

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 # 04.004.000, lot # 7950994

Product
TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILS-EX; Synthes Tibial Nail System EX is intended to stabilize…
Recalling firm
Synthes, Inc.
Quantity
3
Distribution
US Distribution to states of: MO and SC.
Recall date
July 15, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls