Reported Aug 27, 2014 · Terminated
Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set
Synthes, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Synthes, Inc. · 1302 Wrights Ln E · West Chester, PA · 19380-3417
Is this the product you have?
- Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set
- Lot codes and dates
- Part Number145.17E
- Lot NumberEV01609, individual part numbers contained within 145.17E:292.622, and 292.623
304.49309.501310.221310.804311.43312.151312.153313.969314.463314.464314.465319.291319.292319.702319.97398.408398.409402.608-402.640402.714-402.740419.89419.972
- Amount recalled
- 4
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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