Zimmer Periarticular Locking Plate System, Locking Screw Tap Standard Quick-Connect 3.5 mm Diameter, Item Number/EDI 00236015335, Nonsterile. orthopedic surgical instrument.
Reported: October 4, 2017 Initiated: May 22, 2017 #Z-3178-2017
Product Description
Zimmer Periarticular Locking Plate System, Locking Screw Tap Standard Quick-Connect 3.5 mm Diameter, Item Number/EDI 00236015335, 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
- 198 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? ▼
Zimmer Periarticular Locking Plate System, Locking Screw Tap Standard Quick-Connect 3.5 mm Diameter, Item Number/EDI 00236015335, Nonsterile. orthopedic surgical instrument.. Recalled by Zimmer Biomet, Inc.. Units affected: 198 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-3178-2017.
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