FDA Medical Device Recalls (openFDA)
TeDan Surgical Innovations LLC: DS-0024 QUICK START DISTRACTION SCREW 14MM 5/BOX STERILE - Product Usage: These products are intended to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers.
- Recall number
- Z-1506-2020
- Recalling firm
- TeDan Surgical Innovations LLC
- Product
- DS-0024 QUICK START DISTRACTION SCREW 14MM 5/BOX STERILE - Product Usage: These products are intended to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers.
- Status
- Terminated
- Initiated
- 2019-02-18
- Posted
- not on file
- Terminated
- 2021-01-12
- Reason
- 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.
- Root cause
- 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
- Total=146 boxes (48 boxes for Lot 2018022801 and 98 boxes for Lot 2018050801)
- Distribution
- Worldwide.
- Lot, serial or model codes
- Item #: DS-0024 Lot #s: 2018022801 2018050801
- 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
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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