Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported May 24, 2017
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.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Zimmer Gmbh recalled Normed General Instruments 503004541: Werber Countersink Cannulated for micro CBS Screws… - a moderate-severity action.
Normed General Instruments 503004541: Werber Countersink Cannulated for micro CBS Screws… was recalled by Zimmer Gmbh in May 24, 2017. Reason: the devices used a different raw material to produce two countersink products which has higher hardness and …. Check the official notice for the remedy. Verify recall #Z-2111-2017 with the FDA Devices before acting.
The recall
Zimmer Gmbh issued this moderate-severity FDA Devices recall-the devices used a different raw material to produce two countersink products which has higher hardness and ….
- Moderate
- severity level
- Class II
- classification
- May 24, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2111-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2111-2017) was formally reported on May 24, 2017, with the manufacturer initiating the action on May 11, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Zimmer Gmbh is listed as the recalling firm, operating out of Winterthur. Federal records list the affected scope as 138 (OUS 297).
The documented reason for this recall is: 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 data in the federal record shows the product reached: Single US consignee CO.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
138 (OUS 297)
Related Recalls
6
3 from same agency
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2111-2017 |
| Date reported | May 24, 2017 |
| Date initiated | May 11, 2017 |
| Recalling firm | Zimmer Gmbh |
| Firm location | Winterthur |
| Affected scope | 138 (OUS 297) |
| Distribution | Single US consignee CO. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2111-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Zimmer Gmbh. Units affected: 138 (OUS 297).
Why was this product recalled? ▼
the devices used a different raw material to produce two countersink products which has higher hardness and higher carbon content resulting in device damage.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 24, 2017. Severity: Moderate. Recall number: Z-2111-2017.
Where was the recalled product distributed? ▼
Distribution: Single US consignee CO..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2111-2017) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported May 24, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.