FDA Medical Device Recalls (openFDA)
Tedan Surgical Innovations Llc: 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.
- Recall number
- Z-2385-2012
- Recalling firm
- Tedan Surgical Innovations Llc
- 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.
- Status
- Terminated
- Initiated
- 2012-06-11
- Posted
- 2012-09-14
- Terminated
- 2013-07-31
- Reason
- 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.
- Root cause
- 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
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- Firm FEI
- 3005726885
- Firm city
- Sugar Land
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28