FDA-Device2017-05-24Class II
Normed General Instruments 503004541: Werber Countersink Cannulated for micro CBS Screws, AO 503004341: Werber Countersink Cannulated for micro CBS Screws, round-shaft The Countersink is an instrument which is used over the guide wire to prepare for adequate space in the cortical bone rim to sink the screw head in to bones/tissues for different Foot, Ankle and Hand implant systems. The instrument is used in several Normed implant systems. The instrument is used to avoid soft tissue irritation
Zimmer Gmbh
Hazard
the devices used a different raw material to produce two countersink products which has higher hardness and higher carbon content resulting in device damage.
Sold states
Single US consignee CO.
Affected count
138 (OUS 297)
Manufactured in
Sulzer Allee 8, Winterthur, Switzerland
Products
Normed General Instruments 503004541: Werber Countersink Cannulated for micro CBS Screws, AO 503004341: Werber Countersink Cannulated for micro CBS Screws, round-shaft The Countersink is an instrument which is used over the guide wire to prepare for adequate space in the cortical bone rim to sink the screw head in to bones/tissues for different Foot, Ankle and Hand implant systems. The instrument is used in several Normed implant systems. The instrument is used to avoid soft tissue irritation
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2111-2017Don't want to check this manually?
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