FDA Device recall Z-1515-2014
The Osteo-Clage System consists of stainless steel cable/sleeves and compression plates. . 2.0 mm x 850mm SS Cable/Sleeve
- FDA Device
- Class II
- terminated
- Published 2014-05-07
On 2014-05-07 the FDA classified a Class II recall of The Osteo-Clage System consists of stainless steel cable/sleeves and compression plates. . 2.0 mm x 850mm SS Cable/Sleeve by Acumed, citing manufacturing of these devices with a grade of stainless steel that is not within specifications.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1515-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-03-26 |
| Published | 2014-05-07 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Acumed |
| Distribution | US |
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
Manufacturing of these devices with a grade of stainless steel that is not within specifications.
Identifiers
| code_info | 2.0mm x 80mm SS cable/sleeve: Lot # 222078, 232175, 245032, 254368, 261903, 270659, 284155, 297281. 2.0mm SS sleeve…2.0mm x 80mm SS cable/sleeve: Lot # 222078, 232175, 245032, 254368, 261903, 270659, 284155, 297281. 2.0mm SS sleeve only: Lot # 247553, 267469, 280871, 313261. 8, 7 hole SS compression plate: Lot # 300381. 10, 9 hole SS compression plate: Lot # 299641. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1515-2014%22
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