Normed General Instruments 503004541: Werber Countersink Cannulated… — Class II medical device recall Z-2111-2017
Terminated recall by Zimmer Gmbh, reported 2017-05-24. the devices used a different raw material to produce two countersink products which has higher hardness and hi
| Recall number | Z-2111-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Gmbh, Winterthur, Switzerland |
| Recall initiated | 2017-05-11 |
| Classified | 2017-05-18 |
| Reported by FDA | 2017-05-24 |
| Terminated | 2017-11-03 |
| Lot numbers | 13065, 13569, 13571 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2111-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.