Ossur Iceland ehf.
Reykjavik, IS
Ossur Iceland ehf. appears in FDA device records in Reykjavik, IS. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 36 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to Ossur Iceland ehf. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Ossurrecall
- Ossur H / Fenforcement report, recall
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003764610 | 3003764610 | Ossur Iceland ehf. | GRJOTHALS 5, REYKJAVIK 110 IS | 2026 | and 16 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- FQMBandage, Elastic
- FSDBinder, Abdominal
- ISHComponent, External, Limb, Ankle/Foot
- IPMCover, Limb
- IRAHand, External Limb Component, Mechanical
- IQZHand, External Limb Component, Powered
- ITWJoint, Ankle, External Brace
- ITSJoint, Hip, External Brace
- ITQJoint, Knee, External Brace
- ISYJoint, Knee, External Limb Component
- IQKOrthosis, Cervical
- KNPOrthosis, Corrective Shoe
- IQIOrthosis, Limb Brace
- IQEOrthosis, Lumbar
- IPYOrthosis, Lumbo-Sacral
- IPTOrthosis, Thoracic
- IMEPack, Hot Or Cold, Reusable
- ILOPack, Hot Or Cold, Water Circulating
- ISSProsthesis, Thigh Socket, External Component
- IPGShoe, Cast
- ILISling, Arm
- IQJSplint, Clavicle
- NOCSplint, Extremity, Non-Inflatable, External, Non-Sterile
- ILHSplint, Hand, And Components
- IOYSupport, Arm
- KGXTape And Bandage, Adhesive
Recall records
Showing 25 of 36| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0006-2025 | Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101 | Pressure sensitive adhesive hooks attached to the sides of the anterior cervical orthosis collar panel can occasionally exhibit poor adhesion, which may lead to them gradually peeling off with repeated doffing, possibly leading to reduced immobilization of the cervical spine. | Class II | Open, Classified | |
| Z-1790-2024 | RKNXC0005, RHEO KNEE XC 5 YR WARRANTY, MD, CE, External lower limb prosthetic component | Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls. | Class II | Open, Classified | |
| Z-1789-2024 | RKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External lower limb prosthetic component | Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls. | Class II | Open, Classified | |
| Z-1788-2024 | RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic component | Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls. | Class II | Open, Classified | |
| Z-1787-2024 | RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component | Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls. | Class II | Open, Classified | |
| Z-0788-2024 | Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002 | Knee batteries may need replacement with conforming batteries to ensure there isn't a failure to turn on the device, or an unexpected shutdown, which is a momentary loss of power to the knee where the user may experience loss of support that can lead to a fall and potential injury. | Class II | Open, Classified | |
| Z-1906-2023 | 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 | 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. | Class II | Open, Classified | |
| Z-1515-2016 | Ossur Lil Angel Vest P3 Sorbatex. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine. | There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest. | Class II | Terminated | |
| Z-1514-2016 | Ossur Lil Angel Vest P3 Lambswool. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine. | There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest. | Class II | Terminated | |
| Z-1513-2016 | Ossur Lil Angel Vest P3 Kodel. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine. | There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest. | Class II | Terminated | |
| Z-1512-2016 | Ossur Lil Angel Vest P2 Sorbatex. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine. | There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest. | Class II | Terminated | |
| Z-1511-2016 | Ossur Lil Angel Vest P2 Lambswool. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine. | There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest. | Class II | Terminated | |
| Z-1510-2016 | 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. | There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest. | Class II | Terminated | |
| Z-1298-2016 | Papoose Infant Spine Immobilizer Item # Item Description: PA-100 Papoose PAR-100 Papoose w/replacement pads PO-100 Papoose w/o PO front POR-100 Papoose w/o PO front w/pad Product Usage: The Papoose Infant Immobilizer is an external class I orthotic device used to securely immobilize the head and spine in the proper anatomical airway and spinal alignment. The occipital shape protects against positional plagiocephaly. | 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 | Class II | Terminated | |
| Z-1297-2016 | Extreme Custom Product Usage: Extreme Custom is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis. | 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 | Class II | Terminated | |
| Z-1296-2016 | Unloader Custom Product Usage: Unloader Custom is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis. | 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 | Class II | Terminated | |
| Z-1295-2016 | 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. | 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 | Class II | Terminated | |
| Z-1294-2016 | Unloader XT Product Usage: Unloader XT Extreme is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis. | 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 | Class II | Terminated | |
| Z-1293-2016 | Back Support Suspenders Clip on Black Back Support Suspenders Sew on Black | 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 | Class II | Terminated | |
| Z-1292-2016 | Rebound Diabetic Walker Product Usage: Rebound Diabetic Walkers are used for the treatment of plantar foot ulcers. | 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 | Class II | Terminated | |
| Z-1291-2016 | Rebound Air Walker Product Usage: Rebound Air Walkers are indicated for grade 2 and grade 3 ankle sprains, to stabilize fractures, post-operative use, and trauma or rehab use. | 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 | Class II | Terminated | |
| Z-1290-2016 | Rebound Cartilage Custom Product Usage: Rebound Cartilage Custom is an external knee brace that provides support for knee instability due to ligament injuries and osteoarthritis. | 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 | Class II | Terminated | |
| Z-1289-2016 | Rebound Cartilage Product Usage: Rebound Cartilage is an external knee brace that provides support for knee instability due to ligament injuries and osteoarthritis. | 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 | Class II | Terminated | |
| Z-1288-2016 | Miami J Collar Product Usage: Miami J collars are applied to patients afflicted with cervical injuries to ensure immobilization. | 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 | Class II | Terminated | |
| Z-1287-2016 | NecLoc Extrication Collar Product Usage: Necloc collars are applied to patients afflicted with cervical injuries to ensure immobilization. | 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 | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain