Synthes Titanium Polyaxial Reduction Head for Titanium recall
Synthes Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws: The Titanium Polyaxial Reduction Head is a part of the Matrix Spine…
Why was Synthes Titanium Polyaxial Reduction Head for Titanium recalled?
Two nonconforming parts of the Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws may have been inadvertently packaged and shipped. It is believed that the inner diameter of the Reduction Head may not have been machined to the correct specification.
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 Number 04.634.002 Lot Number 6816781
- Product
- Synthes Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws: The Titanium Polyaxial Reduction Head is a part of the Matrix Spine…
- Recalling firm
- Synthes (USA) Products LLC
- Quantity
- 24
- Distribution
- Distributed to MI, MT, and CO.
- Recall date
- December 3, 2014
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)