M/DN Intramedullary Fixation Femoral Drill Large 5.0 mm Item Number/EDI 00225503550, Nonsterile. orthopedic surgical instrument.
Reported: October 4, 2017 Initiated: May 22, 2017 #Z-3160-2017
Product Description
M/DN Intramedullary Fixation Femoral Drill Large 5.0 mm Item Number/EDI 00225503550, 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
- 21 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? ▼
M/DN Intramedullary Fixation Femoral Drill Large 5.0 mm Item Number/EDI 00225503550, Nonsterile. orthopedic surgical instrument.. Recalled by Zimmer Biomet, Inc.. Units affected: 21 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-3160-2017.
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