Zimmer Gmbh: Medical Device Recall in 2017 - (Recall #: Z-2111-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: May 11, 2017

Date Posted: May 24, 2017

Recall Number: Z-2111-2017

Event ID: 77262

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.

Status: Terminated

Product Quantity: 138 (OUS 297)

Code Information:

Lots: 13065 13569 13571

Distribution Pattern:

Single US consignee CO.

Voluntary or Mandated:

Voluntary: Firm initiated