FDAMarch 14, 2016device
Ossur Lil Angel Vest P2 Kodel. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest.
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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