Synthes 3.0 MM TI Cannulated Screw Instrument and recall
Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set
Why was Synthes 3.0 MM TI Cannulated Screw Instrument and recalled?
A screw set was returned from the field for destruction after being exposed to flood water, which was erroneously reprocessed and returned to the field. Initial investigative testing indicated the components within the set may be cytotoxic.
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: 145.17E Lot Number: EV01609, individual part numbers contained within 145.17E: 304.49 309.501 310.221 310.804 311.43 312.151 312.153 313.969 314.463 314.464 314.465 319.291 319.292 319.702 319.97 398.408 398.409 402.608-402.640 402.714-402.740 419.89 419.972 292.622, and 292.623.
- Product
- Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set
- Recalling firm
- Synthes, Inc.
- Quantity
- 4
- Distribution
- Distributed in the states of WI and MI.
- Recall date
- August 27, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)