Device 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
Z-2111-2017
Product summary
- Firm
- Zimmer Gmbh
- Event
- Event 77262
- Status
- Terminated
- Classification
- Class II
- Quantity
- 138 (OUS 297)
- Official record key
device-enforcement:Z-2111-2017
Official wording
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.
Code information: Lots: 13065 13569 13571
Distribution pattern: Single US consignee CO.
Derived failure modes
-
Unknown
the devices used a different raw material to produce two countersink products which has higher hardness and higher carbon content resulting in device damage.