Fixed Offset Adapter — Class II medical device recall Z-0362-2014
Terminated recall by Ossur North America Inc, reported 2013-11-27, distributed in AL, CA, GA, ID, NC, NJ, NY, TX…. Ossur inititated a voluntary recall of the A-642100 Fixed Offset Adapter because it can develop fatigue cracks
| Recall number | Z-0362-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ossur North America Inc, Foothill Ranch, CA, United States |
| Recall initiated | 2013-10-24 |
| Classified | 2013-11-19 |
| Reported by FDA | 2013-11-27 |
| Terminated | 2014-06-17 |
| Distributed | AL, CA, GA, ID, NC, NJ, NY, TX, VA, WI |
| Quantity | 66 units |
| Reason classes | packaging |
| Model numbers | A-642100 |
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 for recall
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.
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-0362-2014. 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.