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U.S. Department of Health and Human Services

Class 2 Device Recall Ossur Sterile

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  Class 2 Device Recall Ossur Sterile see related information
Date Initiated by Firm June 21, 2018
Create Date March 11, 2019
Recall Status1 Terminated 3 on September 04, 2020
Recall Number Z-1001-2019
Recall Event ID 80520
510(K)Number K051918  
Product Classification Tong, skull for traction - Product Code HAX
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 V2 RING KIT TI STD-No App;
515500T/ CB RING KIT TI LG-No App;
515500V2/ OB V2 RING KIT TI LG-No App;
515300T/ CB RING KIT TI SM-No App;
515400T/ CB RING KIT TI STD-No App;
515301T/ CB RING KIT TI SM 8-No APP;
515301V2/ OB V2 RING KIT TI SM 8-No App;
515401T/ CB RING KIT TI STD 8-No APP;
515401V2/ OB V2 RING KIT TI STD 8-No APP;
515501T/ CB RING KIT TI LG 8-No App;
515501V2/ OB V2 RING KIT TI LG 8-No App;
540T/ STERILE TITANIUM COMP TRAY;
540V2/ STERILE V2 COMPONENT TRAY
Code Information All lots of the products manufactured from 06/30/2009 - 12/13/2018  
Recalling Firm/
Manufacturer
Ossur Americas
27051 Towne Centre Dr
Foothill Ranch CA 92610-2804
For Additional Information Contact Scott Brandon Powis
800-233-6263
Manufacturer 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.
FDA Determined
Cause 2
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 affected product, if they desire to do so. Customers were asked to distribute the notices to those who need to be aware within their organization or to any department areas where the potentially affected devices were used or transferred. On 01/14/2019, Urgent Medical Device Recall letters were sent via express mail requiring a signature of acceptance from the customer. Customers were advised: Please examine your inventory, quarantine products subject to the recall and contact customer service for a return authorization to return the product. In addition: 1. Please confirm receipt of this recall notice by calling customer service (800-233-6263) or visit https://safetyalert.ossur.com 2. Please pass this notice to those who need to be aware within your organization and to any department areas where the potentially affected devices will be used or transferred (e.g. MR Imaging, Surgical, Emergency, Material Management, Patient) 3. Maintain awareness on this notice for an appropriate period. 4. If you have further distributed this product, please identify your customers and notify them at once of this product alert. We recommend that you include a copy of this product recall. 5. If any of your patients is currently wearing the product, necessary arrangements should be made to ensure the patient is not placed in MR Imaging.
Quantity in Commerce 182
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
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HAX and Original Applicant = JEROME MEDICAL
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