Home / Recalls / Medical Devices
Synthes (USA) Products LLC recalls Synapse System 3.5mm TI Cancellous Polyaxial Screws, Part No. 04.615.026 for use in spinal surgery
Recalled November 6, 2019 · FDA recall Z-0223-2020 · Synthes (USA) Products
Hazard
The subject product measures 4.0mm in diameter instead of 3.5mm. · FDA Class II
Units
6
Sold at
Distributed to NJ.
Description
The subject product measures 4.0mm in diameter instead of 3.5mm.
Product
Synapse System 3.5mm TI Cancellous Polyaxial Screws, Part No. 04.615.026 for use in spinal surgery
Manufacturer(s)
Synthes (USA) Products LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →