Ossur Americas recalls
Ossur Americas appears in 14 official U.S. recall notices indexed by RecallRadar, most recently on 2022-10-05.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 14 |
|---|---|
| Published | 2014-02-12 to 2022-10-05 |
| By agency | FDA Device (14) |
| By classification | Class II (14) |
| By status | terminated (13), ongoing (1) |
| Distribution named in notices | AK, AL, AZ, CA, DC, DE, FL, GA, HI, IL, IN, KY, MA, MI, MN, MS, NC, NE, NJ, NM, NY, OH, OK, PA, RI, SC, TN, TX, US, UT, VA, WA |
Recalls
- OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA01001L OSSUR Power Knee REF PKA01001T
FDA Device · Class II · 2022-10-05 · Ossur Americas
Reason: Battery may dislodge from the Power Knee - OSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis, sized for children and adolescents
FDA Device · Class II · 2022-07-13 · Ossur Americas
Reason: 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. - Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR-101 Instructions for Use
FDA Device · Class II · 2021-12-22 · Ossur Americas
Reason: Instructions for use were updated to include additional information to facilitate the selection and use of the collar device. - OSSUR MIAMI J SELECT COLLAR - Product Usage: is intended to provide gross immobilization to the cervical spine
FDA Device · Class II · 2021-06-23 · Ossur Americas
Reason: Due to insufficient column strength of the racks for all load conditions, racks associated with height adjustment functionality have been observed deforming, which may lead to increased range of motion in the cervical s… - Ossur Skull Pin, Sterile Titanium Pin, Part/Description: 516TS/ Skull Pin 2-1/4in TI Sterl 1PK
FDA Device · Class II · 2019-03-20 · Ossur Americas
Reason: Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label mistakenly lists ceramic tip.… - Ossur OB Resolve, Sterile, Part/ Description: 505300D/ OB RESOLVE STERILE RING SML
FDA Device · Class II · 2019-03-20 · Ossur Americas
Reason: Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label mistakenly lists ceramic tip.… - Ossur Skull Pin, Sterile Ceramic Tip Pin, Part/ Description: 516CS/ Skull Pin 2-1/4in CT Sterl 1PK
FDA Device · Class II · 2019-03-20 · Ossur Americas
Reason: Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label mistakenly lists ceramic tip.… - Ossur CB Resolve, Sterile, Part/ Description: 505300C/ CB RESOLVE STERILE UNIT SML
FDA Device · Class II · 2019-03-20 · Ossur Americas
Reason: Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label mistakenly lists ceramic tip.… - Ossur, Sterile, Part/ Description: 505300T/ CB RING KIT TI SM
FDA Device · Class II · 2019-03-20 · Ossur Americas
Reason: Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label mistakenly lists ceramic tip.… - Ossur, LIL Angel Vest, Part/ Description: 545100K/ LIL ANGEL VEST P2 KODEL
FDA Device · Class II · 2019-03-20 · Ossur Americas
Reason: Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label mistakenly lists ceramic tip.… - Ossur, ReSolve Halo Vest, Part/ Description: 545700K/ ReSolve Halo Vest-shrt kodel
FDA Device · Class II · 2019-03-20 · Ossur Americas
Reason: Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label mistakenly lists ceramic tip.… - Ossur, J Tong, Sterile, Part/ Description: JT-115/ J TONG MED/LGE-No App
FDA Device · Class II · 2019-03-20 · Ossur Americas
Reason: Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label mistakenly lists ceramic tip.… - The SYMBIONIC LEG is an integrated prosthetic leg for transfemoral and knee disarticulation amputees
FDA Device · Class II · 2014-03-05 · Ossur Americas
Reason: OSSUR is recalling the Symbionic Leg because it is not recognizing the low battery warning signal from the Symbionic Leg before it powers down. - The Symbionic Leg is an integrated prosthetic leg for transfemoral and knee disarticulation amputees
FDA Device · Class II · 2014-02-12 · Ossur Americas
Reason: OSSUR initiated this recall of the Symbionic Leg because it may have a possible defect in a small batch of electronics.