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U.S. Department of Health and Human Services

Class 2 Device Recall Sterile Distraction Screws of 3 different sizes

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  Class 2 Device Recall Sterile Distraction Screws of 3 different sizes see related information
Date Initiated by Firm June 11, 2012
Date Posted September 14, 2012
Recall Status1 Terminated 3 on July 31, 2013
Recall Number Z-2385-2012
Recall Event ID 62899
Product Classification Orthopedic manual surgical instrument - Product Code LXH
Product Sterile Distraction Screws of 3 different sizes: 12mm, 14mm and 16mm sold under TSI, 3COR, DB Surgical, and American Surgical Products brands and Sterile XL Screws of 7 different sizes: 90mm, 100mm, 110mm, 120mm, 130mm, 140mm, 150mm sold under TSI brand

Sterile Distraction Screws are intended for the distraction in the anterior approach to the cervical spine. Sterile XL Screws are intended for the fixation of the blade to the vertebral body to prohibit drifting in the extreme lateral approach to the lumbar spine.
Code Information Lot numbers: 019715, 019716, 019942, 019943, 019977, 019978, 020102, 020103, 020104, 020105, 020106, 020107, 020108, 020609, 020782,  021539, 021663, 022097, 022098, 022099, 022122, 022123, 022124, 022371, 022372, 022790, 022791, 022792, 022794, 022795, 022796, 022827, 022828, and 023266.
Recalling Firm/
Manufacturer		 Tedan Surgical Innovations Llc
12615 W Airport Blvd
Ste 200
Sugar Land TX 77478-6203
For Additional Information Contact Terry Hernandez
713-726-0886
Manufacturer Reason
for Recall		 This letter is to notify you that several of our sterile screw products are being voluntarily recalled. Product sterility may be compromised due to a mechanical failure of the protective packaging tube. Tube end plugs may dislodge creating the potential for the screw to come out of the protective tube and then the sharp end of the screw pierce the outer sterile barrier pouch.
FDA Determined
Cause 2		 Packaging
Action The firm, TeDan Surgical Innovations (TSI), sent an "URGENT: Medical Device Recall" letter dated June 11, 2012 to their consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine their inventory and quarantine all products subject to recall and return product to TSI. In addition, if they have further distributed this product, identify all customers and notify them of this product recall at once in writing; and complete and return the enclosed Mandatory Response Form as soon as possible and no later than June 25, 2012 via mail: 12675 W. Airport Blvd., Suite 200, Sugar Land, TX 77478; fax: (713) 726-0846 or email: thernandez@tedansurgical.com. If you have any questions, contact the Business Manager at 713-726-0886, Monday thru Friday, from 8am - 5pm or via email at THERNANDEZ@TEDANSURGICAL.COM.
Quantity in Commerce 12,065 Sterile Distraction Screws (2413 boxes); 384 Sterile XL Screws (128 boxes) in distribution
Distribution Worldwide distribution: USA (nationwide) and countries of : Australia and Taiwan.
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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