FDA Device recall Z-2111-2017
Normed General Instruments 503004541: Werber Countersink Cannulated for micro CBS Screws, AO 503004341: Werber Countersink Cannulated for m…
- FDA Device
- Class II
- terminated
- Published 2017-05-24
On 2017-05-24 the FDA classified a Class II recall of Normed General Instruments 503004541: Werber Countersink Cannulated for micro CBS Screws, AO 503004341: Werber Countersink Cannulated for m… by Zimmer, citing the devices used a different raw material to produce two countersink products which has higher hardness and higher carbon content resulting in device damage.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2111-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-05-11 |
| Published | 2017-05-24 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer |
| Distribution | CO |
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.
Identifiers
| code_info | Lots: 13065 13569 13571 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2111-2017%22
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