Z-0997-2019 Class II Terminated
FDA device recall Z-0997-2019 was initiated by Ossur Americas on June 21, 2018 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated September 4, 2020). Affected quantity: 372.
Recall Details
- Product Type
- Devices
- Report Date
- March 20, 2019
- Initiation Date
- June 21, 2018
- Termination Date
- September 4, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 372
Product Description
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
Reason for Recall
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.
Distribution Pattern
U.S.: HI, AL, CA, WA, AZ, TX, NM, NE, MI, IL, MN, MS, IN, OH, KY, TN, AK, AL, UT, SC, NC, GA, PA, FL, NY, DE, RI, VA, MA; Foreign: Australia, Germany, New Zealand, Belgium
Code Information
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