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
This recall is currently active, issued December 28, 2020. It was issued by New Standard Device Inc.
- Company
- New Standard Device Inc
- Recall Initiated
- December 28, 2020
- Recall Number
- Z-1649-2022
- Quantity
- 410 total devices
- Firm Location
- San Antonio, TX
- Official Source
- View on FDA website ↗
Reason for Recall
Complaints were received for Self-drill Half-Pin tip breakages occurring during surgery.
Distribution
U.S.: AZ, GA, IL MT, NC, NJ, NV, OH, PA, TX, and VA O.U.S.: None
Lot / Code Info
Part Number / DESCRIPTION / UDI-DI Code / Lot Numbers: 620030 / Self-Drill Half-Pin 5x30x215mm / 854641008198 / A29418X, A17219CA 620040 / Self-Drill Half-Pin 5x40x215mm / 854641008204 / A29418Y, A17219CB 620060 / Self-Drill Half-Pin 5x60x215mm / 854641008211 / A29418Z, A17219CC 620080 / Self-Drill Half-Pin 5x80x215mm / 854641008228 / A29518A, A17219CD
Root Cause
Device Design
Action Taken
On 12/28/2020, Metalogix send a "Field Notice: Self-Drill Half-Pin" via email. The Notice only informed customer that the Citieffe Half-Pins will temporarily be used to replace the current 5mm Self-Drill Half-Pins. A contact number for Mr. Elton Ely, QA Manager was provided in the notice 833-659-2019 ext. 6