Ossur Fixed Offset Adapter Recalled for Fatigue Cracks and Separation Risk
Ossur North America Inc is voluntarily recalling 66 units of the A-642100 Fixed Offset Adapter because the component can develop fatigue cracks and separate completely during normal use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a structural defect in a medical device (prosthetic component) that can lead to complete separation, which aligns with the rubric criterion for 'structural vehicle defect' or significant injury risk, warranting a Severe rating.
Plain-English summary
Ossur North America Inc has initiated a voluntary recall of the A-642100 Fixed Offset Adapter. This fixed modular component is made of high-strength alloy and is intended to offset the tube 14.5 mm (0.57 inch) from the center line of the pyramid in prosthetic applications. It is fully compatible with all standard 30mm prosthetic pylons.
The recall is being conducted because the adapter can develop fatigue cracks in normal use over an extended period of time, which can ultimately lead to complete separation of the component. The recall involves 66 units with Item Number A-642100 and all serial numbers.
The affected products were distributed in the United States, including the states of Alabama, Texas, New York, California, Virginia, Georgia, Wisconsin, North Carolina, Idaho, and New Jersey. Users of these prosthetic components should contact Ossur North America Inc for further instructions on how to proceed with the recall.
The recalled product
- 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…
- Manufacturer
- Ossur North America Inc
- Affected units
- 66
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Item Number: A-642100 All Serial Numbers.
Distribution
Related recalls
Same hazard · structural failure
See all →- High
- ModerateQuantum Ops Recalls ADAPTABLE Beach Chair Surgical Patient Positioners
FDA (Devices) · 2026-10-14
- SevereMedline Bariatric Rollator Recalled Due to Front Wheel Assembly Disconnect Risk
FDA (Devices) · 2026-10-14
- SevereMedline Bariatric Rollator Recalled Due to Front Wheel Detachment Risk
FDA (Devices) · 2026-10-14
- SeverePacearth Recalls Swing Seats Due to Serious Injury Risk from Falling
CPSC · 2026-10-08
Similar recalls
- SevereOssur LP Rotate Foot System Recalled for Insecure Assembly
FDA (Devices) · 2015-03-25
- ModerateArthrosurface Recalls Uncleared Taper Post Fixation Components
FDA (Devices) · 2015-02-18
- HighArthrosurface Shoulder Prosthetic Components Recalled for Marketing Clearance Issues
FDA (Devices) · 2015-02-18
- HighOssur Recalls Rebound Air Walkers and Other Medical Devices
FDA (Devices) · 2016-04-06
- ModerateArthrosurface Shoulder Prosthesis Components Recalled for Lack of US Clearance
FDA (Devices) · 2015-02-18
- HighProsthetic Socket Ratchet Locking Systems Recalled for Suspension Loss Risk
FDA (Devices) · 2023-06-21