Power Knee Prosthetic Batteries Recalled Due to Unexpected Shutdown Risk
Ossur Power Knee prosthetic knee batteries may fail to turn on or shut down unexpectedly, potentially causing users to lose support and fall. Affected units are distributed nationwide.
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 is a medical device recall (FDA Class II) involving risk of device failure that could lead to falls and injury. While no illnesses or injuries have been reported to date, the source describes a theoretical risk-of-harm scenario, placing it at the High severity level per the rubric.
Plain-English summary
Ossur H/F is recalling Power Knee prosthetic knee batteries due to potential failure to power on or unexpected shutdown during use. The recalled batteries may result in a momentary loss of power to the knee, leaving the wearer without support.
Loss of support while wearing the prosthetic can lead to a fall and potential injury. The recall affects Power Knee devices (REF: PKA10001 and PKA10003) distributed throughout the United States.
Users of affected Power Knee units should contact Ossur H/F for battery replacement with conforming batteries that meet safety standards. Specific affected serial numbers are available in the FDA recall notice.
The recalled product
- Product
- Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002
- Manufacturer
- Ossur H / F
- Category
- Medical Device — Prosthetic Limb
- Hazard
- unexpected-shutdown
- fall-risk
- device-failure
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 (20)
- REF/UDI-DI: PKA10001/05690967648381
- PKA10003/05690967648749
- PKA10002/05690967648404. Knee/Battery Serial Numbers: HF511036 HF551398
- HF511050 HF551935
- HF511065 HF552267
- HF511072 HF551258
- HF511081 HF552479
- HF511082 HF551327
- HF511084 HF552406
- HF511096 HF551301
- HF511098 HF551215
- HF511099 HF551366
- HF511104 HF551409
- HF511105 HF552404
- HF511119 HF551282
- HF511121 HF552298
- HF511122 HF551400
- HF511123 HF552314
- HF511124 HF552333
- HF511128 HF552414
Distribution
Distributed nationwide across the United States.
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