Recall Z-0998-2019 ยท LYT Fixation Accessory
Ossur Americas
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
| Date | Jun 21, 2018 |
| Status | Terminated |
| 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. |
| Root cause | Labeling design |
| Action | On 06/21/2018, Urgent Field Safety Notices were mailed to customers via UPS Next-Day Air requiring a signature of acceptance from the customer. Customers were advised the following: 1. Please pass this notice to those who need to be aware within your organization or to any department areas where the potentially affected devices will be used or transferred. 2. Maintain awareness on this notice for an appropriate period. 3. If you would like to have the product replaced please contact your customer service or sales representative and new product will be provided. Customers can exchange the affe |
| Quantity | 824 |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040363 | CERAMIC TIPPED SKULL PIN The Jerome Group, Inc., Apr 12, 2004 |