Reported Jan 31, 2024 · Ongoing
Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002
Ossur H / F
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ossur H / F · Grjothals 5 · Reykjavik, N/A · N/A
Is this the product you have?
- Power Knee
- REF
PKA10001and PKA10003with Power Knee Battery
- REFPKA10002
- Lot codes and dates
- REF/UDI-DI
PKA10001/05690967648381PKA10003/05690967648749PKA10002/05690967648404
- Knee/Battery Serial Numbers
533 of 533 codes
HF511036 HF551398HF511050 HF551935HF511065 HF552267HF511072 HF551258HF511081 HF552479HF511082 HF551327HF511084 HF552406HF511096 HF551301HF511098 HF551215HF511099 HF551366HF511104 HF551409HF511105 HF552404HF511119 HF551282HF511121 HF552298HF511122 HF551400HF511123 HF552314HF511124 HF552333HF511128 HF552414HF511130 HF552339HF511131 HF552315HF511132 HF552271HF511133 HF552268HF511136 HF552316HF511137 HF552332HF511138 HF552310HF511139 HF552483HF511142 HF552294HF511144 HF551368HF511148 HF552401HF511149 HF552317HF511150 HF552471HF511151 HF552251HF511163 HF552394HF511164 HF552311HF511165 HF552470HF511168 HF552326HF511169 HF551279HF511170 HF552309HF511171 HF552407HF511173 HF551477HF511178 HF552485HF511179 HF551344HF511181 HF552392HF511182 HF551347HF511183 HF551275/HF552399HF511185 HF552290HF511187 HF552331HF511188 HF552256HF511191 HF552249HF511192 HF552308HF511193 HF551346HF511194 HF552284HF511195 HF551216HF511198 HF552241HF511199 HF551321HF511200 HF552335HF511201 HF552260HF511242 HF551226HF511257 HF552327HF511267 HF552277
- REF/UDI-DI
- Amount recalled
- 544 Batteries
Where it was sold
Why it was recalled
Knee batteries may need replacement with conforming batteries to ensure there isn't a failure to turn on the device, or an unexpected shutdown, which is a momentary loss of power to the knee where the user may experience loss of support that can lead to a fall and potential injury.
This product could cause temporary or reversible health problems — stop using it.
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