The Recall Desk

FDA (Devices) recall action 80520

Ossur Americas recalled 8 products on 2019-03-20

The FDA (Devices) publishes a recall like this one as 8 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 8 pages.

Products
8
Announced
2019-03-20
Critical
0
Units
2,940

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–8 of 8

  • ModerateFDA (Devices)··2019-03-20

    Ossur ReSolve Halo Vest Recalled for Labeling and Safety Testing Issues

    Ossur Americas is recalling 381 ReSolve Halo Vests because the titanium pin label incorrectly lists a ceramic tip and the products require confirmatory safety testing.

    Product
    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
    Category
    Distribution
    28 states
  • ModerateFDA (Devices)··2019-03-20

    Ossur CB Resolve Halo System Recalled for Labeling and Testing Issues

    Ossur Americas is recalling 656 units of CB Resolve Halo system products due to a labeling error and the need for confirmatory safety testing.

    Product
    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…
    Category
    Distribution
    28 states
  • ModerateFDA (Devices)··2019-03-20

    Ossur LIL Angel Vest Recalled for Labeling and Safety Testing Issues

    Ossur Americas is recalling 45 LIL Angel Vests because the titanium pin labels incorrectly list ceramic tips and require confirmatory safety testing.

    Product
    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
    Category
    Distribution
    28 states
  • ModerateFDA (Devices)··2019-03-20

    Ossur Skull Pin Recall Due to Labeling Error and Safety Testing

    Ossur Americas is recalling 372 sterile titanium skull pins because the label incorrectly lists a ceramic tip and the products require confirmatory safety testing.

    Product
    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
    Category
    Distribution
    28 states
  • ModerateFDA (Devices)··2019-03-20

    Ossur J Tong Sterile Medical Device Recall for Labeling Error

    Ossur Americas is recalling 138 units of J Tong sterile medical devices because the titanium pin label incorrectly lists a ceramic tip.

    Product
    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
    Category
    Distribution
    28 states
  • ModerateFDA (Devices)··2019-03-20

    Ossur Skull Pin Recall for Labeling Error and Safety Testing

    Ossur Americas is recalling 824 sterile skull pins due to a label error and pending safety testing.

    Product
    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…
    Category
    Distribution
    28 states
  • ModerateFDA (Devices)··2019-03-20

    Ossur OB Resolve Sterile Ring Kits Recalled for Labeling Errors

    Ossur Americas is recalling 342 units of OB Resolve sterile ring kits due to a labeling error on titanium pins and pending safety testing.

    Product
    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…
    Category
    Distribution
    28 states
  • ModerateFDA (Devices)··2019-03-20

    Ossur Halo System Ring Kits Recalled for Labeling and Safety Testing

    Ossur Americas is recalling 182 units of Halo system ring kits due to a labeling error and the need for confirmatory safety testing.

    Product
    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…
    Category
    Distribution
    28 states