medical Class II Updated 2019-03-20

Ossur Americas recalls Ossur Skull Pin, Sterile Titanium Pin, Part/Description:

Recalled 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

Hazard / Issue

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.

Issued by

FDA

Affected States: HI, AL, CA, WA, AZ, TX, NM, NE, MI, IL, MN, MS, IN, OH, KY, TN, AK, UT, SC, NC, GA, PA, FL, NY, DE, RI, VA, MA

Lot/Code Info: All lots of the products manufactured from 06/30/2009 - 12/13/2018 Titanium Pin Label Mistakenly lists Ceramic Tip, Part/Lot numbers: 516TS/ AL18021418 and AL17022109; 520TS/ AL18021417 and AL15091012

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