Z-2111-2017Class II

Normed General Instruments 503004541: Werber Countersink Cannulated for micro CBS Screws, AO 503004341...

Name: Z-2111-2017 Normed General Instruments 503004541: Werber Countersink Cannulated for micro CBS Screws, AO 503004341...
Creator: Zimmer Gmbh
Published: 2017-05-11
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2017-05-11 / Terminated / root cause: manufacturing process

FDA source

Zimmer Gmbh began a recall of Normed General Instruments 503004541: Werber Countersink Cannulated for micro CBS Screws, AO 503004341: Werber Countersink Cannulated for micro CBS Screws... on 2017-05-11. FDA classified it as Class II and gives the reason as "the devices used a different raw material to produce two countersink products which has higher hardness and higher carbon content resulting in device damage". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2111-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-11
Posted: 2017-05-15
Terminated: 2017-11-03
Recalling firm: Zimmer GmbH
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
Product code: HTT Burr, Orthopedic
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 138 (OUS 297)
Distribution: Single US consignee CO.
Product codes and lots: Lots: 13065 13569 13571

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2111-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2111-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-24	2017-05-18

Product code HTT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)