Z-3201-2017 Class II Terminated

Recalled by Zimmer Biomet, Inc. — Warsaw, IN

Recall Details

Product Type
Devices
Report Date
October 4, 2017
Initiation Date
May 22, 2017
Termination Date
March 29, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,037 units

Product Description

Zimmer Natural Nail System Freehand Drill 4.3 mm Diameter 152.5 mm Length, Item Number/EDI 00249007543, 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.

Distribution Pattern

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

Code Information

Lot Numbers: 63541085, 63565537, 63586553, 63586554, 63635381, 63635382, 63660536, 63329874, 63329875, 63343934, 63343935, 63361695, 63370747, 63388956, 63399691, 63399692, 63413799, 63413801, 63413803, 63413804 & 63499022.