FDAFebruary 24, 2016device
Unloader Custom Lite Product Usage: Unloader Custom Lite is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound Air Walker, Rebound Diabetic Walker, Back Support Suspenders Clip on Black, Back Support Suspenders Sew On Black, Extreme Custom, Unloader Custom XT, Unloader Custom Lite, Unloader Custom, and Papoose Infant Spine Immobilizers because the p
What to do
FDA enforcement status: Terminated
Brands named
ossur h fossur
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAMiami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-1012024-08-20
- FDARKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic component2024-03-25
- FDARKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External lower limb prosthetic component2024-03-25
- FDARKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component2024-03-25
- FDARKNXC0005, RHEO KNEE XC 5 YR WARRANTY, MD, CE, External lower limb prosthetic component2024-03-25
- FDAPower Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA100022023-12-26
- FDAIcelock 125 Ratchet, REF: L-125000; Icelock 600XM Ratchet, REF: L-621200; Icelock 621 Ratchet, REF: L-621000; Icelock 621 Ratchet Adaption Kit, REF: L-621100; Ratchet Lock Body, REF: L-6920202023-05-12
- FDAOSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA01001L OSSUR Power Knee REF PKA01001T2022-08-29
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