Reported May 24, 2017 · Terminated
Normed General Instruments 503004541: Werber Countersink Cannulated for micro CBS Screws, AO 503004341: Werber…
Zimmer GmbH
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: Zimmer Gmbh · Sulzer Allee 8 · Winterthur · N/A
Is this the product you have?
- Normed General Instruments 503004541Werber Countersink Cannulated for micro CBS Screws
- AO 503004341Werber 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
- Lot codes and dates
- Lots13065 13569 13571
- Amount recalled
- 138 (OUS 297)
Where it was sold
Why it was recalled
the devices used a different raw material to produce two countersink products which has higher hardness and higher carbon content resulting in device damage.
This product could cause temporary or reversible health problems — stop using it.
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