PlainRecalls
FDA Devices Moderate Class II Terminated

NCB Periprosthetic Plate System Drill Bit With Quick-Coupling 4.5 mm Diameter 195 mm Length, Item Number/EDI 0200024330, Nonsterile. orthopedic surgical instrument.

Reported: October 4, 2017 Initiated: May 22, 2017 #Z-3157-2017

Product Description

NCB Periprosthetic Plate System Drill Bit With Quick-Coupling 4.5 mm Diameter 195 mm Length, Item Number/EDI 0200024330, Nonsterile. orthopedic surgical instrument.

Reason for Recall

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Details

Recalling Firm
Zimmer Biomet, Inc.
Units Affected
185 units
Distribution
Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled?
NCB Periprosthetic Plate System Drill Bit With Quick-Coupling 4.5 mm Diameter 195 mm Length, Item Number/EDI 0200024330, Nonsterile. orthopedic surgical instrument.. Recalled by Zimmer Biomet, Inc.. Units affected: 185 units.
Why was this product recalled?
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
Which agency issued this recall?
This recall was issued by the FDA Devices on October 4, 2017. Severity: Moderate. Recall number: Z-3157-2017.