Synthes Trauma Nail System. The devices are indication recall
Synthes Trauma Nail System. The devices are indication for bone fixation.
Why was Synthes Trauma Nail System. The devices are indication recalled?
Recall was initiated due to the possibility that the outer pouch was compromised. The product is packaged in two pouches; a sterile, internal pouch within an external pouch. It is the outer, external pouch that may be compromised.
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?
Trauma Ex Nails, all lot numbers up to and including lot # 7072305 and Trochanteric Fixation Nails, all lot numbers up to and including lot # 7060897
- Product
- Synthes Trauma Nail System. The devices are indication for bone fixation.
- Recalling firm
- Synthes USA HQ, Inc.
- Quantity
- 1,011,783
- Distribution
- Nationwide distribution.
- Recall date
- September 4, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)