Synthes (USA) Products LLC recalls Synapse System 3.5mm TI Cancellous Polyaxial Screws, Part No. 04.615.026 for use in spinal surgery
- Recall date
- September 16, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0223-2020
- FDA classification
- Class II
- Brand / firm
- Synthes (USA) Products LLC
- Sold / distributed
- Distributed to NJ.
Why it was recalled
The subject product measures 4.0mm in diameter instead of 3.5mm.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Synapse System 3.5mm TI Cancellous Polyaxial Screws, Part No. 04.615.026 for use in spinal surgery
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