FDA Device recall Z-0998-2019
Ossur Skull Pin, Sterile Ceramic Tip Pin, Part/ Description: 516CS/ Skull Pin 2-1/4in CT Sterl 1PK
- FDA Device
- Class II
- terminated
- Published 2019-03-20
On 2019-03-20 the FDA classified a Class II recall of Ossur Skull Pin, Sterile Ceramic Tip Pin, Part/ Description: 516CS/ Skull Pin 2-1/4in CT Sterl 1PK by Ossur Americas, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0998-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-06-21 |
| Published | 2019-03-20 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ossur Americas |
| Distribution | AK, AL, AZ, CA, DE, FL, GA, HI, IL, IN, KY, MA, MI, MN, MS, NC, NE, NM, NY, OH, PA, RI, SC, TN, TX, UT, VA, WA |
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 CT 6 PK
Reason
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.
Identifiers
| code_info | All lots of the products manufactured from 06/30/2009 - 12/13/2018 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0998-2019%22
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