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
Recall
- Recall Number
- Z-2111-2017
- Event Number
- 77262
- FEI Number
- 3005233524
- Product Code
- HTT
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- May 11, 2017
- Posted
- May 15, 2017
- Terminated
- November 3, 2017
- Address
- Zimmer Gmbh Sulzer Allee 8 Winterthur Switzerland
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
the devices used a different raw material to produce two countersink products which has higher hardness and higher carbon content resulting in device damage.
Zimmer Biomet sent an URGENT MEDICAL DEVICE RECALL REMOVAL letter dated May 11 2017. Lot Specific notifications were sent to the affected consignee via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers with questions were instructed to call Technical Services at 1-574-371-3071.
Single US consignee CO.
138 (OUS 297)