OSSUR Power Knee Prosthetics Recalled for Battery Dislodgement Risk
OSSUR Power Knee prosthetics are being recalled because the battery may dislodge from the device. Approximately 190 units are affected across the United States.
What this means for you
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: This FDA Class II recall involves a risk-of-harm product (powered prosthetic) with potential battery dislodgement. No reported injuries or hospitalizations, meeting the High severity threshold per the rubric for risk-of-harm products without reported injury.
Plain-English summary
The FDA has issued a Class II recall for OSSUR Power Knee prosthetics. This recall affects approximately 190 devices with specific model numbers PKA10001, PKA10003, PKA01001L, and PKA01001T.
The recalled Power Knee devices may experience battery dislodgement. Specific serial numbers have been identified for each model variant.
The affected devices were distributed nationwide across 37 U.S. states including Alabama, Arizona, California, Florida, Georgia, Hawaii, Illinois, and many others. Both patient-use units and loaner devices are included in this recall.
Consumers in possession of affected OSSUR Power Knee prosthetics should contact their prosthetist or Ossur Americas for further instructions.
The recalled product
- Product
- OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA01001L OSSUR Power Knee REF PKA01001T
- Manufacturer
- Ossur Americas
- Hazard
- battery-dislodgement
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 (7)
- Model Number / UDI-DI Code PKA10001 / 05690967648381 Serial Numbers: HF511081
- HF511095
- HF511100
- HF511102
- HF511116
- HF511133
- HF511323
Distribution
Distributed nationwide across the United States.
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