PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: May 24, 2017 Initiated: May 11, 2017 #Z-2111-2017

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.

Details

Recalling Firm
Zimmer Gmbh
Units Affected
138 (OUS 297)
Distribution
Single US consignee CO.
Location
Winterthur

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.

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