Metalogix Self-Drill Half-Pin — Class II medical device recall Z-1649-2022
Ongoing recall by New Standard Device Inc, reported 2022-09-07, distributed in AZ, GA, IL, MT, NC, NJ, NV, OH…. Complaints were received for Self-drill Half-Pin tip breakages occurring during surgery.
| Recall number | Z-1649-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | New Standard Device Inc, San Antonio, TX, United States |
| Recall initiated | 2020-12-28 |
| Classified | 2022-08-29 |
| Reported by FDA | 2022-09-07 |
| Distributed | AZ, GA, IL, MT, NC, NJ, NV, OH, PA, TX, VA |
| Quantity | 410 devices |
| UPC / GTIN / UDI-DI | 00854641008198, 00854641008204, 00854641008211, 00854641008228 |
| Lot numbers | 5X30X215MM, 5X40X215MM, 5X60X215MM, 5X80X215MM, 620030, 620040, 620060, 620080, A17219CA, A17219CB, A17219CC, A17219CD, A29418X, A29418Y, A29418Z, A29518A |
| Model numbers | 620030, 620040, 620060, 620080 |
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 for recall
Complaints were received for Self-drill Half-Pin tip breakages occurring during surgery.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1649-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.