Z-2111-2017 Class II Terminated
FDA device recall Z-2111-2017 was initiated by Zimmer Gmbh on May 11, 2017 and is designated Class II. 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. The recall status is terminated (terminated November 3, 2017). Affected quantity: 138 (OUS 297).
Recall Details
- Product Type
- Devices
- Report Date
- May 24, 2017
- Initiation Date
- May 11, 2017
- Termination Date
- November 3, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 138 (OUS 297)
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.
Distribution Pattern
Single US consignee CO.
Code Information
Lots: 13065 13569 13571