Synthes Tensioning Device The Synthes Osteogenesis recall
Synthes Tensioning Device The Synthes Osteogenesis System, MR Conditional is intended for fracture fixation (open and closed), pseudoarthrosis or…
Why was Synthes Tensioning Device The Synthes Osteogenesis recalled?
All lots of the Synthes Tensioning Device were recalled due to the potential for the reaction fork to come loose from the main body of the device and not allow the wire to release, nor the device to apply tension.
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 model number 03.311.001: Part # Synthes lot # 03.311.001 1934765 03.311.001 1934766 03.311.001 1993844 03.311.001 3036688 03.311.001 3398576 03.311.001 3776484 03.311.001 5100597 03.311.001 5106354 03.311.001 5160872 03.311.001 5160875 03.311.001 5174253 03.311.001 5174253 03.311.001 5174254 03.311.001 5181000 03.311.001 5181001 03.311.001 5196282 03.311.001 5196283 03.311.001 5197081 03.311.001 5241942 03.311.001 5241943 03.311.001 5336723 03.311.001 5363637 03.311.001 5396016 03.311.001 5411479 03.311.001 5555521
- Product
- Synthes Tensioning Device The Synthes Osteogenesis System, MR Conditional is intended for fracture fixation (open and closed), pseudoarthrosis or…
- Recalling firm
- Synthes USA HQ, Inc.
- Quantity
- 369
- Distribution
- Nationwide Distribution.
- Recall date
- December 4, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)