Recall Z-2111-2017— Zimmer Gmbh
Class II · Terminated
Class II FDA medical device recall by Zimmer Gmbh, initiated 2017-05-11, terminated 2017-11-03. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: the devices used a different raw material to produce two countersink products which has higher hardness and higher carbon content resulting in device damage..
- Recalling firm
- Zimmer Gmbh
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-05-11
- Terminated
- 2017-11-03
- Firm location
- Winterthur, Switzerland
Product description
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
Reason for recall
the devices used a different raw material to produce two countersink products which has higher hardness and higher carbon content resulting in device damage.
Data sourced from openFDA. This site is unofficial and independent of the FDA.