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Zimmer Gmbh recalls Normed General Instruments 503004541: Werber Countersink Cannulated for micro CBS Screws, AO 503004341: Werber Counters
Recalled May 24, 2017 · FDA recall Z-2111-2017 · Zimmer
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. · FDA Class II
Units
138 (OUS 297)
Sold at
Single US consignee CO.
Description
the devices used a different raw material to produce two countersink products which has higher hardness and higher carbon content resulting in device damage.
Product
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
Manufacturer(s)
Zimmer Gmbh
Made in
Switzerland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →