Medical DeviceOct 5, 2022
OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA01001L recall — FDA Z-1821-2022
Battery may dislodge from the Power Knee
Class IIFDA: OngoingOssur Americas
Recall history in this database
Classification mix: Class II: 2.
Medical DeviceJul 13, 2022
OSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis, sized for children and recall — FDA Z-1330-2022
Due to receiving complaints related to broken (cracked) prosthetic foot with failures occurring in situations where sudden high impact twisting or bending is applied to the foot.
Class IIFDA: TerminatedOssur Americas
Understanding this recall history
This page summarizes recall records in which the official source identifies Ossur Americas as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.