The Osteo-Clage System consists of stainless steel cable/sleeves and… — Class II medical device recall Z-1515-2014
Terminated recall by Acumed LLC, reported 2014-05-07, distributed nationwide. Manufacturing of these devices with a grade of stainless steel that is not within specifications.
| Recall number | Z-1515-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Acumed LLC, Hillsboro, OR, United States |
| Recall initiated | 2014-03-26 |
| Classified | 2014-04-25 |
| Reported by FDA | 2014-05-07 |
| Terminated | 2015-02-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CN, ES, FR, GB, IT, JP, KR, SE, ZA |
| Lot numbers | 2.0MMSS, 222078, 232175, 245032, 247553, 254368, 261903, 267469, 270659, 280871, 284155, 297281, 299641, 300381, 313261 |
| Model numbers | 01-0020-S, 01-0022-S, 2.0 |
Product
The Osteo-Clage System consists of stainless steel cable/sleeves and compression plates. . 2.0 mm x 850mm SS Cable/Sleeve; Part Number 01-0020-S 2.0 mm SS Sleeve Only; Part Number 01-0022-S 8, 7 hole, SS compression plate; Part Number 02-2007-S 10, 9 hole, SS compression plate; Part Number 02-2009-S Product Usage: The Osteo-Clage Stainless Steel Bone Plate is an implantable straight, rigid stainless steel plate. It is used in conjunction with 4.5mm Cortical bone screws to provide compression across bone fractures. The Osteo-Clage Cerclage Wire Crimp sleeve is used in conjunction with the bone plate in cerclage fixation procedures
Reason for recall
Manufacturing of these devices with a grade of stainless steel that is not within specifications.
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-1515-2014. 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.