Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self-Drill Half-Pin 5x30x215mm REF 620030 Metalogix Self-Drill Half-Pin 5x40x215mm REF 620040 Metalogix Self-Drill Half-Pin 5x60x215mm REF 620060 Metalogix Self-Drill Half-Pin 5x80x215mm REF 620080
Reported: September 7, 2022 Initiated: December 28, 2020 #Z-1649-2022
Product Description
Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self-Drill Half-Pin 5x30x215mm REF 620030 Metalogix Self-Drill Half-Pin 5x40x215mm REF 620040 Metalogix Self-Drill Half-Pin 5x60x215mm REF 620060 Metalogix Self-Drill Half-Pin 5x80x215mm REF 620080
Reason for Recall
Complaints were received for Self-drill Half-Pin tip breakages occurring during surgery.
Details
- Recalling Firm
- New Standard Device Inc
- Units Affected
- 410 total devices
- Distribution
- U.S.: AZ, GA, IL MT, NC, NJ, NV, OH, PA, TX, and VA O.U.S.: None
- Location
- San Antonio, TX
Frequently Asked Questions
What product was recalled? ▼
Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self-Drill Half-Pin 5x30x215mm REF 620030 Metalogix Self-Drill Half-Pin 5x40x215mm REF 620040 Metalogix Self-Drill Half-Pin 5x60x215mm REF 620060 Metalogix Self-Drill Half-Pin 5x80x215mm REF 620080. Recalled by New Standard Device Inc. Units affected: 410 total devices.
Why was this product recalled? ▼
Complaints were received for Self-drill Half-Pin tip breakages occurring during surgery.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 7, 2022. Severity: Moderate. Recall number: Z-1649-2022.
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