Skip to content

Ossur

United Statesfrom the FDA registration address FDA establishment FEI 3008395545

Devices
0
Registrations
FDA
FDA recalls
6

No devices from this company are in the catalogue yet.

Company details

FDA FEI number
3008395545
Address
606 Broadway, Newburgh, NY, 12550

FDA recalls6

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

  • 2008

    • 26 Sep 2008 Z-0594-2009 Unclassified (pre-2012) Terminated Ossur has initiated this voluntary recall as a precautionary measure because the firm is unable to guarantee the sterility of the affected products. Distribution: Nationwide Distribution --- including states of FL, KS, MI, MO, NY, & WA. Submission numbers: K023959, K040363
    • 26 Sep 2008 Z-0595-2009 Unclassified (pre-2012) Terminated Ossur has initiated this voluntary recall as a precautionary measure because the firm is unable to guarantee the sterility of the affected products. Distribution: Nationwide Distribution --- including states of FL, KS, MI, MO, NY, & WA. Submission numbers: K023959, K040363
    • 26 Sep 2008 Z-0596-2009 Unclassified (pre-2012) Terminated Ossur has initiated this voluntary recall as a precautionary measure because the firm is unable to guarantee the sterility of the affected products. Distribution: Nationwide Distribution --- including states of FL, KS, MI, MO, NY, & WA. Submission numbers: K023959, K040363

  • 2007

    • 2 Apr 2007 Z-1076-2007 Unclassified (pre-2012) Terminated Some units of the Total Knee Model 2100 produced from August 1, 2006 through October 4, 2006 may contain a faulty linkage component. Distribution: Nationwide.

  • 2006

    • 3 Nov 2006 Z-0468-2007 Unclassified (pre-2012) Terminated Inner Tube Breakage: distributed low quality units can lead to breakage of the inner tube, resulting in an abrupt rotation of the shock module, compromising function and stability of the prosthetic foot Distribution: Nationwide in US plus Worldwide distribution in Canada, Austria, Switzerland, Czech Republic, Germany, Spain, France,…
      Full distribution text Nationwide in US plus Worldwide distribution in Canada, Austria, Switzerland, Czech Republic, Germany, Spain, France, United Kingdom, Greece, Israel, Italy, Netherlands and Norway.

  • 2005

    • 21 Oct 2005 Z-0388-06 Unclassified (pre-2012) Terminated After one year devices assembled with a new type of O-rings could exhibit enough wear to allow a gradual oil leak which would increase play in the ankle sub-assembly of the foot. Distribution: Nationwide

This is an FDA establishment record without devices in deviCERTS.