FDAClass IIAugust 26, 2015

Synthes Tibial Nail Wrap Holds 11 Nails and Synthes recall

Synthes Tibial Nail Wrap Holds 11 Nails and Synthes Intramedullary Nail Wrap Holds 10 Nails; the Nail Wrap is intended to be used as a protective…

Why was Synthes Tibial Nail Wrap Holds 11 Nails and Synthes recalled?

The wrap is for single use for nail sterilization but does not have sufficient testing for the device to be considered a multi-use item.

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 numbers: 900.50, 900.51

Product
Synthes Tibial Nail Wrap Holds 11 Nails and Synthes Intramedullary Nail Wrap Holds 10 Nails; the Nail Wrap is intended to be used as a protective…
Recalling firm
Synthes (USA) Products LLC
Quantity
1487
Distribution
Worldwide Distribution - US Distribution including Puerto Rico and to the countries of : Canada, Switzerland and New Zealand.
Recall date
August 26, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls