Zimmer Gmbh recalls Normed General Instruments 503004541: Werber Countersink Cannulated for micro CBS Screws, AO 503004341: Werber Counters…

Recall date

May 11, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2111-2017

FDA classification

Class II

Brand / firm

Zimmer Gmbh

Sold / distributed

Single US consignee CO.

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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