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U.S. Department of Health and Human Services

Class 2 Device Recall 3COR Distraction Screws

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  Class 2 Device Recall 3COR Distraction Screws see related information
Date Initiated by Firm February 18, 2019
Create Date March 17, 2020
Recall Status1 Terminated 3 on January 12, 2021
Recall Number Z-1503-2020
Recall Event ID 84252
Product Classification Orthopedic manual surgical instrument - Product Code LXH
Product D-0012 3COR 12MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and the TSI Quick Start Distraction Screws products are intended for the distraction in the anterior approach to the cervical spine from C2 thru C7. The products are to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers.
Code Information Item #: D-0012 Lot #: 2018011601 
Recalling Firm/
Manufacturer		 TeDan Surgical Innovations LLC
12615 W Airport Blvd Ste 200
Sugar Land TX 77478-6203
For Additional Information Contact Danny Fishman
713-568-3403
Manufacturer Reason
for Recall		 The items identified for recall are labeled as sterile. However, the manufacturer has found that product packaging for the lots listed above may be damaged, potentially exposing the product to non sterile conditions. This situation presents a risk of infection to patients.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action On 02/21/2019 the firm issued a recall notice to affected consignees. The recall notification informed the consignees of the following: Customers should immediately remove all identified products and contact TSI to receive an RMA and shipping instructions. 2. Contact information for returns: Name: Nicole Burrell or Val Saucedo Telephone: 713 726-0886 Email address: custservice@ tedansurgica.com Fax 713 726-0846 In addition, if you have distributed the identified product to end users, immediately identify all customers and notify them of this product recall in writing using the enclosed information. Your assistance is appreciated and necessary to prevent any possible injury to patients. Also as needed provide to these customers the attached recall response form for their completion and provide to TSI the name, address, and contact information for those customers. Other TSI distraction screws not identified as part of this recall may be used. However, as a precaution, always follow the instructions for use and carefully inspect sterile packaging for any breaches. If breaches are identified DO NOT USE THE PRODUCT and contact TSI immediately.
Quantity in Commerce 49 boxes (245 individual screws)
Distribution Worldwide.
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.
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