FDA Device recall Z-0362-2014
Fixed Offset Adapter, A-642100
- FDA Device
- Class II
- terminated
- Published 2013-11-27
On 2013-11-27 the FDA classified a Class II recall of Fixed Offset Adapter, A-642100 by Ossur North America, citing ossur inititated a voluntary recall of the A-642100 Fixed Offset Adapter because it can develop fatigue cracks in normal use over an extended period of time and ultimately separat….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0362-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-10-24 |
| Published | 2013-11-27 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ossur North America |
| Distribution | AL, CA, GA, ID, NC, NJ, NY, TX, VA, WI |
Product
Fixed Offset Adapter, A-642100. The Offset Adapter is a fixed modular component which sets the tube 14.5 mm (0.57 inch) offset from the center line of the pyramid. It is made of a high-strength alloy with a pyramid receiver and is intended where there is a need to offset the tube horizontally in relation to other components. It is fully compatible with all standard 30mm prosthetic pylons. (3) Offset: 14,5mm (0.57inch).
Reason
Ossur inititated a voluntary recall of the A-642100 Fixed Offset Adapter because it can develop fatigue cracks in normal use over an extended period of time and ultimately separate completely.
Identifiers
| code_info | Item Number: A-642100 All Serial Numbers. |
|---|
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-0362-2014%22
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