FDAFDA · Food and drugs·Recall number Z-2111-2017
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
Published May 24, 2017 · Recall initiated: May 11, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Zimmer Gmbh
- Distributor
- Single US consignee CO.
- Lot
- Lots: 13065 13569 13571
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Switzerland
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