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 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/ OB
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 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 2-1/4
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 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 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 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 Ap
Category
Distribution
28 states