Ability Dynamics Recalls RUSH81 Prosthetic Feet Due to Bolt Failure Risk
Ability Dynamics is recalling 175 RUSH81 prosthetic feet because existing bolts may be bottomed out in threaded holes, which could lead to bolt failure.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the source text identifies a mechanical defect (bolt failure) that poses a risk of harm to users, but no injuries or illnesses have been reported.
Plain-English summary
Ability Dynamics LLC is recalling 175 units of the RUSH81 Prosthetic Foot. The recall was initiated because the existing bolts in the device may be bottomed out in the threaded hole. This condition could lead to bolt failure.
The affected prosthetic feet were distributed nationwide in the United States, as well as in Australia and Canada. The recall covers specific serial numbers listed in the official FDA record.
Consumers who possess a RUSH81 Prosthetic Foot should check the serial number against the list provided by the FDA or Ability Dynamics. If the device is affected, users should contact Ability Dynamics for instructions on how to proceed with the recall.
The recalled product
- Product
- RUSH81 Prosthetic Foot Product Usage: Prosthetic foot for human use
- Manufacturer
- Ability Dynamics LLC
- Hazard
- Affected units
- 175
Distribution
Distributed nationwide across the United States.
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