Ossur Americas
680 Grove Rd, West Deptford, NJ, US
Registered product codes
15 product codes
Recent MDR events
54 on file
- MIAMI J SELECT COLLAR SETOct 1, 2025Injury23187757
- MIAMI J SELECT COLLAR SETJul 16, 2025Malfunction22519411
- REBOUND AIR WALKERApr 10, 2024InjuryMW5153728
- OSSUR MIAMI J SELECT COLLARJul 22, 2022Malfunction15083957
- RESOLVE HALOJun 9, 2021Death1836248-2021-00001
- MIAMI JR OCCIAN BACKDec 3, 2020Malfunction10940008
- TOTAL KNEE 2100Oct 9, 2020Injury0001836248-2020-00003
- TOTAL KNEE 2000Apr 15, 2020Injury0001836248-2020-00001
- RESOLVE HALOApr 15, 2020Injury0001836248-2020-00002
- MIAMI J-400 REGULARMar 26, 2020MalfunctionMW5093940
Recalls
14 on file
- Open, ClassifiedSep 28, 2022
Battery may dislodge from the Power Knee
View FDA record ↗ - TerminatedFeb 26, 2014
OSSUR is recalling the Symbionic Leg because it is not recognizing the low battery warning signal from the Symbionic Leg before it powers down.
View FDA record ↗ - TerminatedFeb 6, 2014
OSSUR initiated this recall of the Symbionic Leg because it may have a possible defect in a small batch of electronics.
View FDA record ↗ - TerminatedUnknown
Instructions for use were updated to include additional information to facilitate the selection and use of the collar device.
View FDA record ↗ - TerminatedUnknown
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.
View FDA record ↗ - TerminatedUnknown
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.
View FDA record ↗ - TerminatedUnknown
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.
View FDA record ↗ - TerminatedUnknown
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.
View FDA record ↗ - TerminatedUnknown
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.
View FDA record ↗ - TerminatedUnknown
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.
View FDA record ↗
Compliance history
Matched by FEI 2242474.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.