Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 27, 2013
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).
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…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Ossur North America Inc recalled Fixed Offset Adapter, A-642100. The Offset Adapter is a fixed modular component which … - a moderate-severity action.
Fixed Offset Adapter, A-642100. The Offset Adapter is a fixed modular component which … was recalled by Ossur North America Inc in November 27, 2013. Reason: Ossur inititated a voluntary recall of the A-642100 Fixed Offset Adapter because it can develop fatigue crack…. Check the official notice for the remedy. Verify recall #Z-0362-2014 with the FDA Devices before acting.
The recall
Ossur North America Inc issued this moderate-severity FDA Devices recall-Ossur inititated a voluntary recall of the A-642100 Fixed Offset Adapter because it can develop fatigue crack….
- Moderate
- severity level
- 66 units
- affected scope
- Class II
- classification
- November 27, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0362-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0362-2014) was formally reported on November 27, 2013, with the manufacturer initiating the action on October 24, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Ossur North America Inc is listed as the recalling firm, operating out of Foothill Ranch, CA. Federal records list the affected scope as 66 units.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: US Distribution including the states of AL, TX, NY, CA, VA, GA, WI, NC, ID and NJ.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
66 units
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0362-2014 |
| Date reported | November 27, 2013 |
| Date initiated | October 24, 2013 |
| Recalling firm | Ossur North America Inc |
| Firm location | Foothill Ranch, CA |
| Affected scope | 66 units |
| Distribution | US Distribution including the states of AL, TX, NY, CA, VA, GA, WI, NC, ID and NJ. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0362-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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).. Recalled by Ossur North America Inc. Units affected: 66 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 27, 2013. Severity: Moderate. Recall number: Z-0362-2014.
Where was the recalled product distributed? ▼
Distribution: US Distribution including the states of AL, TX, NY, CA, VA, GA, WI, NC, ID and NJ..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0362-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 27, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.