Recall Z-2111-2017 ยท HTT Burr, Orthopedic
Zimmer Gmbh
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
| Date | May 15, 2017 (initiated May 11, 2017) |
| Status | Terminated |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 138 (OUS 297) |
| Distribution | Single US consignee CO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.