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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

FDA Recall Z-2111-2017 · Posted 2017-05-15

Recalling FirmZimmer Gmbh
Recall StatusTerminated
Product CodeHTT
Date Initiated2017-05-11
Date Terminated2017-11-03
Product Quantity138 (OUS 297)

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Single US consignee CO.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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