Ossur Americas FDA Recalls

4 recalls on file across devices, 0 of them Class I and 1 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA01001L OSSUR Power Knee REFClass IIAug 29, 2022Battery may dislodge from the Power Knee	Battery may dislodge from the Power Knee	Class IIDevices	Aug 29, 2022
OSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis, sized for children and adolescents.Class IIMay 30, 2022Due to receiving complaints related to broken (cracked) pros	Due to receiving complaints related to broken (cracked) prosthetic foot with failures occurring in situations	Class IIDevices	May 30, 2022
Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR-101 Instructions for UseClass IINov 9, 2021Instructions for use were updated to include additional info	Instructions for use were updated to include additional information to facilitate the selection and use of the	Class IIDevices	Nov 9, 2021
OSSUR MIAMI J SELECT COLLAR - Product Usage: is intended to provide gross immobilization to the cervical spine. REF: Class IIJun 1, 2021Due to insufficient column strength of the racks for all loa	Due to insufficient column strength of the racks for all load conditions, racks associated with height adjustm	Class IIDevices	Jun 1, 2021