Z-3158-2017 Class II Terminated
FDA device recall Z-3158-2017 was initiated by Zimmer Biomet, Inc. on May 22, 2017 and is designated Class II. 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 instr… The recall status is terminated (terminated March 29, 2019). Affected quantity: 182 units.
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
- 182 units
Product Description
M/DN Intramedullary Fixation Distal Drill Pilot Tip 3.2 mm Diameter, Item Number/EDI 00225503332, 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: 63574676, 63574677, 63574678, 63424385, 63451742, 63493677 & 63493680