FDA Device recall Z-1649-2022
Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System
- FDA Device
- Class II
- ongoing
- Published 2022-09-07
On 2022-09-07 the FDA classified a Class II recall of Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System by New Standard Device, citing complaints were received for Self-drill Half-Pin tip breakages occurring during surgery.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1649-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-12-28 |
| Published | 2022-09-07 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | New Standard Device |
| Distribution | AZ, GA, IL, MT, NC, NJ, NV, OH, PA, TX, VA |
Product
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
Complaints were received for Self-drill Half-Pin tip breakages occurring during surgery.
Identifiers
| code_info | Part Number / DESCRIPTION / UDI-DI Code / Lot Numbers: 620030 / Self-Drill Half-Pin 5x30x215mm / 854641008198 / A29418X…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1649-2022%22
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