Ossur Americas
West Deptford, NJ, US
OSSUR AMERICAS appears in FDA device records in West Deptford, NJ. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show 21 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Ossur Americas 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.
- Ossur North America Incenforcement report, recall
510(k) clearance history
FDA records hold 1 510(k) clearance for Ossur Americas in 2013.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2013 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2242474 | 2242474 | OSSUR AMERICAS | 680 Grove Rd, West Deptford, NJ 08086 US | 2026 | and 5 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- ISHComponent, External, Limb, Ankle/Foot
- IPMCover, Limb
- IRAHand, External Limb Component, Mechanical
- IQZHand, External Limb Component, Powered
- ITWJoint, Ankle, External Brace
- ITQJoint, Knee, External Brace
- ISYJoint, Knee, External Limb Component
- IQKOrthosis, Cervical
- IQEOrthosis, Lumbar
- IPYOrthosis, Lumbo-Sacral
- ISSProsthesis, Thigh Socket, External Component
- JOWSleeve, Limb, Compressible
- ILISling, Arm
- IQJSplint, Clavicle
- ILHSplint, Hand, And Components
- IOYSupport, Arm
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1821-2022 | OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA01001L OSSUR Power Knee REF PKA01001T | Battery may dislodge from the Power Knee | Class II | Open, Classified | |
| Z-1330-2022 | OSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis, sized for children and adolescents. | 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. | Class II | Terminated | |
| Z-0380-2022 | Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR-101 Instructions for Use | Instructions for use were updated to include additional information to facilitate the selection and use of the collar device. | Class II | Terminated | |
| Z-1896-2021 | OSSUR MIAMI J SELECT COLLAR - Product Usage: is intended to provide gross immobilization to the cervical spine. REF: MJS-101; MJSR-101 | 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 spine. | Class II | Terminated | |
| Z-1004-2019 | Ossur, LIL Angel Vest, Part/ Description: 545100K/ LIL ANGEL VEST P2 KODEL; 545100L/ LIL ANGEL VEST P2 LAMBSWOOL; 545100S/ LIL ANGEL VEST P2 SORBATEX; 545150K/ LIL ANGEL VEST P3 KODEL; 545150L/ LIL ANGEL VEST P3 LAMBSWOOL; 545150S/ LIL ANGEL VEST P3 SORBATEX | 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 second line description should state titanium pin. | Class II | Terminated | |
| Z-1003-2019 | Ossur, ReSolve Halo Vest, Part/ Description: 545700K/ ReSolve Halo Vest-shrt kodel; 545700L/ ReSolve Halo Vest-shrt lmbwool; 545800K/ ReSolve Halo Vest-tall kodel; 545800L/ ReSolve Halo Vest-tall lmbwool | 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 second line description should state titanium pin. | Class II | Terminated | |
| Z-1002-2019 | Ossur, J Tong, Sterile, Part/ Description: JT-115/ J TONG MED/LGE-No App; JT-200/ J TONG ASSEMBLY SML/MED; JT-210/ J TONG ONLY SML/MED; JT-400/ J TONG COMPONENT TRAY | 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 second line description should state titanium pin. | Class II | Terminated | |
| Z-1001-2019 | Ossur, Sterile, Part/ Description: 505300T/ CB RING KIT TI SM; 505300V2/ OB V2 RING KIT TI SM; 505400T/ CB RING KIT TI STD; 505400V2/ OB V2 RING KIT TI STD; 505500T/ CB RING KIT TI LG; 505500V2/ OB V2 RING KIT TI LG; 515300V2/ OB V2 RING KIT TI SM-No App; 515400V2/ OB V2 RING KIT TI STD-No App; 515500T/ CB RING KIT TI LG-No App; 515500V2/ OB V2 RING KIT TI LG-No App; 515300T/ CB RING KIT TI SM-No App; 515400T/ CB RING KIT TI STD-No App; 515301T/ CB RING KIT TI SM 8-No APP; 515301V2/ OB V2 RING KIT TI SM 8-No App; 515401T/ CB RING KIT TI STD 8-No APP; 515401V2/ OB V2 RING KIT TI STD 8-No APP; 515501T/ CB RING KIT TI LG 8-No App; 515501V2/ OB V2 RING KIT TI LG 8-No App; 540T/ STERILE TITANIUM COMP TRAY; 540V2/ STERILE V2 COMPONENT TRAY | 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 second line description should state titanium pin. | Class II | Terminated | |
| Z-1000-2019 | Ossur CB Resolve, Sterile, Part/ Description: 505300C/ CB RESOLVE STERILE UNIT SML; 505400C/ CB RESOLVE STERILE UNIT STD; 505500C/ CB Resolve Sterile Unit LRG; 515300C/ CB RESOLVE RING KIT SM-No App; 515400C/ CB RESOLVE RING KIT STD-No App; 515500C/ CB RESOLVE RING KIT LG-No App; 540C/ CB RESOLVE COMPONENT TRAY; 553CB/ CB RING TRAY SM; 554CB/ CB RING TRAY STD; 555CB/ CB RING TRAY LG; 505301C/ Kit Closed Back Halo Sm; 505401C/ Kit Closed Back Halo Md; 505501C/ Kit Closed Back Halo Lg | 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 second line description should state titanium pin. | Class II | Terminated | |
| Z-0999-2019 | Ossur OB Resolve, Sterile, Part/ Description: 505300D/ OB RESOLVE STERILE RING SML; 505400D/ OB RESOLVE RING KIT STD; 505500D/ OB RESOLVE RING KIT LRG; 515300D/ OB RESOLVE RING KIT SM-No App; 515400D/ OB RESOLVE RING KIT STD-No App; 515500D/ OB RESOLVE RING KIT LG-No App; 540D/ OB RESOLVE COMPONENT TRAY | 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 second line description should state titanium pin. | Class II | Terminated | |
| Z-0998-2019 | Ossur Skull Pin, Sterile Ceramic Tip Pin, Part/ Description: 516CS/ Skull Pin 2-1/4in CT Sterl 1PK; 516DS/ Skull Pin 3in CT Sterl 1PK; 517CS/ Skull Pin 2-1/4in CT Sterl 4PK; 517DS/ Skull Pin 3in CT Sterl 4 PK; 522CS/ Skull Pin 2-1/4in CT Sterl 6PK; 522C/ SKULL PIN 2-1/4 CT 6 PK | 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 second line description should state titanium pin. | Class II | Terminated | |
| Z-0997-2019 | Ossur Skull Pin, Sterile Titanium Pin, Part/Description: 516TS/ Skull Pin 2-1/4in TI Sterl 1PK; 516V2S/ Skull Pin 3in TI Sterl 1PK; 520TS/ Skull Pin 2-1/4in TI Sterl 5PK; 520V2S/ Skull Pin 3in TI Sterl 5 PK | 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 second line description should state titanium pin. | Class II | Terminated | |
| Z-0362-2014 | Fixed Offset Adapter, A-642100. The Offset Adapter is a fixed modular component which sets the tube 14.5 mm (0.57 inch) offset from the center line of the pyramid. It is made of a high-strength alloy with a pyramid receiver and is intended where there is a need to offset the tube horizontally in relation to other components. It is fully compatible with all standard 30mm prosthetic pylons. (3) Offset: 14,5mm (0.57inch). | Ossur inititated a voluntary recall of the A-642100 Fixed Offset Adapter because it can develop fatigue cracks in normal use over an extended period of time and ultimately separate completely. | Class II | Terminated | |
| Z-1097-2014 | The SYMBIONIC LEG is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. Product Usage: SYMBIONIC LEG is intended for continuous use by amputees of low to moderate impact levels that weigh less than 125 kg for foot categories 25 30 and less than 100kg for foot categories 22, 23 and 24. The system is not intended for athletic use. | OSSUR is recalling the Symbionic Leg because it is not recognizing the low battery warning signal from the Symbionic Leg before it powers down. | Class II | Terminated | |
| Z-0936-2014 | The Symbionic Leg is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. The prosthesis is composed of the RHEO KNEE and the PROPRIO FOOT, both already existing products from ssur. Both are a battery powered micro-processor controlled prosthetic device and are connected through a shared battery. The knee and the foot have different sensor systems that provide real-time information used to control knee joint resistance and the flexion/extension of the ankle during the gait cycle. Default control parameters are provided with the device but can be manually adjusted by a certified prosthetist through software (knee), or by a certified prosthetist or the user through controls on the device itself (foot). SYMBIONIC LEG is intended for continuous use by amputees of low to moderate impact levels that weigh less than 125 kg for foot categories 25 30 and less than 100kg for foot Categories 22, 23 and 24. The system is not intended for athletic use. | OSSUR initiated this recall of the Symbionic Leg because it may have a possible defect in a small batch of electronics. | Class II | Terminated | |
| Z-1200-06 | Ossur Total Knee 2100, Model Number TK 2100, external prosthetic knee. | The company's initiation of the recall is based on a finding that some units of the Total Knee device may contain faulty pins based in the axis of the knee. Small cracks propagate through the pin cross section until the pin breaks, severely compromising the knee function. | Terminated | ||
| Z-1199-06 | Ossur Total Knee 2000, Model Number TK 2000, external prosthetic knee. | The company's initiation of the recall is based on a finding that some units of the Total Knee device may contain faulty pins based in the axis of the knee. Small cracks propagate through the pin cross section until the pin breaks, severely compromising the knee function. | Terminated | ||
| Z-1198-06 | Ossur Total Knee 1900, Model Number TK 1900, external prosthetic knee. | The company's initiation of the recall is based on a finding that some units of the Total Knee device may contain faulty pins based in the axis of the knee. Small cracks propagate through the pin cross section until the pin breaks, severely compromising the knee function. | Terminated | ||
| Z-1197-06 | Ossur Total Knee Junior, Model Number TK 1100, External Prosthetic knee. | The company's initiation of the recall is based on a finding that some units of the Total Knee device may contain faulty pins based in the axis of the knee. Small cracks propagate through the pin cross section until the pin breaks, severely compromising the knee function. | Terminated | ||
| Z-1083-04 | VSP Shock Module (as part of a prosthetic foot). | Flawed shock module might cause breakage causing patient to fall. | Terminated | ||
| Z-0815-03 | Mauch XG, Caron Knee Frame. Model numbers FDM01804U, FRM01804LU, FRM01851U, FRM61750. | Knee frame defect lead to breakage and injury. Knee bolt end came loose. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain