Ossur H / F
Complete recall history across all FDA and CPSC categories — 29 total recalls
Ossur H / F appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (29)
FDA medical device enforcement actions by Ossur H / F
| Date | Product | Reason | Class |
|---|---|---|---|
| Aug 20, 2024 | Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: ... | Pressure sensitive adhesive hooks attached to the sides of the anterior cervi... | Class II |
| Mar 25, 2024 | RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic co... | Due to firmware issues with the prosthetic knee, there is the potential for u... | Class II |
| Mar 25, 2024 | RKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External lower limb prosthetic... | Due to firmware issues with the prosthetic knee, there is the potential for u... | Class II |
| Mar 25, 2024 | RKNXC0005, RHEO KNEE XC 5 YR WARRANTY, MD, CE, External lower limb prosthetic... | Due to firmware issues with the prosthetic knee, there is the potential for u... | Class II |
| Mar 25, 2024 | RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic co... | Due to firmware issues with the prosthetic knee, there is the potential for u... | Class II |
| Dec 26, 2023 | Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002 | Knee batteries may need replacement with conforming batteries to ensure there... | Class II |
| May 12, 2023 | Icelock 125 Ratchet, REF: L-125000; Icelock 600XM Ratchet, REF: L-621200; I... | A mechanical lock used to connect and release a locking liner into a prosthet... | Class II |
| Mar 14, 2016 | Ossur Lil Angel Vest P2 Lambswool. Pediatric sized vest is a support structu... | There is a potential for partial or complete fracture of the plastic stabiliz... | Class II |
| Mar 14, 2016 | Ossur Lil Angel Vest P2 Sorbatex. Pediatric sized vest is a support structu... | There is a potential for partial or complete fracture of the plastic stabiliz... | Class II |
| Mar 14, 2016 | Ossur Lil Angel Vest P3 Lambswool. Pediatric sized vest is a support structur... | There is a potential for partial or complete fracture of the plastic stabiliz... | Class II |
| Mar 14, 2016 | Ossur Lil Angel Vest P3 Sorbatex. Pediatric sized vest is a support structure... | There is a potential for partial or complete fracture of the plastic stabiliz... | Class II |
| Mar 14, 2016 | Ossur Lil Angel Vest P3 Kodel. Pediatric sized vest is a support structure u... | There is a potential for partial or complete fracture of the plastic stabiliz... | Class II |
| Mar 14, 2016 | Ossur Lil Angel Vest P2 Kodel. Pediatric sized vest is a support structure u... | There is a potential for partial or complete fracture of the plastic stabiliz... | Class II |
| Feb 24, 2016 | Knee Shield (Patella Cup) Product Usage: Knee Shield patella cup is an ac... | Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gra... | Class II |
| Feb 24, 2016 | Rebound Diabetic Walker Product Usage: Rebound Diabetic Walkers are used ... | Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gra... | Class II |
| Feb 24, 2016 | Unloader Custom Product Usage: Unloader Custom is an external knee braces... | Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gra... | Class II |
| Feb 24, 2016 | NecLoc Extrication Collar Product Usage: Necloc collars are applied to pa... | Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gra... | Class II |
| Feb 24, 2016 | Miami J Collar Product Usage: Miami J collars are applied to patients aff... | Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gra... | Class II |
| Feb 24, 2016 | Extreme Custom Product Usage: Extreme Custom is an external knee braces t... | Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gra... | Class II |
| Feb 24, 2016 | Unloader XT Product Usage: Unloader XT Extreme is an external knee braces... | Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gra... | Class II |
| Feb 24, 2016 | Back Support Suspenders Clip on Black Back Support Suspenders Sew on Black | Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gra... | Class II |
| Feb 24, 2016 | Knee Undersleeve Gray Product Usage: Knee undersleeves are worn as an acc... | Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gra... | Class II |
| Feb 24, 2016 | Rebound Cartilage Product Usage: Rebound Cartilage is an external knee br... | Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gra... | Class II |
| Feb 24, 2016 | Rebound Cartilage Custom Product Usage: Rebound Cartilage Custom is an ex... | Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gra... | Class II |
| Feb 24, 2016 | Papoose Infant Spine Immobilizer Item # Item Description: PA-100 Papoose P... | Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gra... | Class II |
| Feb 24, 2016 | Unloader Custom Lite Product Usage: Unloader Custom Lite is an external ... | Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gra... | Class II |
| Feb 24, 2016 | Rebound Air Walker Product Usage: Rebound Air Walkers are indicated for g... | Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gra... | Class II |
| Mar 4, 2015 | LP Rotate Foot System prosthetic device for fitting lower extremity amputati... | The threads of the outer tube of the shock module of LP Rotate are too short,... | Class II |
| Feb 26, 2015 | The Rheo Knee bionic prosthetic is to be used exclusively for fittings of low... | The firm is recalling Rheo Knee bionic prosthetic due to it being discovered ... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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