FDAMay 12, 2023device
Icelock 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-692020
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
A mechanical lock used to connect and release a locking liner into a prosthetic socket have an attachment pin and lock that can wear down faster than expected, leading to the potential for the pin to disengage from the lock, leading to loss of suspension of the external prosthetic system that replaces a missing lower limb, which can lead to falling and injury.
What to do
FDA enforcement status: Ongoing
Brands named
ossur h fossur
UPCs
0569096756614205690967596590056909671183340569096715532205690967128548
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
- FDARKNXC0005, RHEO KNEE XC 5 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
- 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
- FDAPower Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA100022023-12-26
- FDAOSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA01001L OSSUR Power Knee REF PKA01001T2022-08-29
- FDAOSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis, sized for children and adolescents.2022-05-30
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