FDAClass IINovember 6, 2019

Synapse System 3.5mm TI Cancellous Polyaxial Screws recall

Synapse System 3.5mm TI Cancellous Polyaxial Screws, Part No. 04.615.026 for use in spinal surgery

Why was Synapse System 3.5mm TI Cancellous Polyaxial Screws recalled?

The subject product measures 4.0mm in diameter instead of 3.5mm.

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?

10L2702

Product
Synapse System 3.5mm TI Cancellous Polyaxial Screws, Part No. 04.615.026 for use in spinal surgery
Recalling firm
Synthes (USA) Products LLC
Quantity
6
Distribution
Distributed to NJ.
Recall date
November 6, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
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