FDA Medical Device Recalls (openFDA)
TeDan Surgical Innovations LLC: PHANTOM CS QUICK START DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
- Recall number
- Z-2529-2020
- Recalling firm
- TeDan Surgical Innovations LLC
- Product
- PHANTOM CS QUICK START DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
- Status
- Terminated
- Initiated
- 2020-05-15
- Posted
- not on file
- Terminated
- 2022-09-08
- Reason
- Lack of pouch seal. Product is labelled as sterile.
- Root cause
- Packaging change control
- Action
- On June 4, 2020, the firm sent an "URGENT: MEDICAL DEVICE FIELD SAFETY NOTICE" along a "Field Safety Notice Acknowledgement and Receipt Form Response Required" to customers via email informing them the Recaling Firm has received two (2) complaints associated with the packaging issue where there was no seal on the screw pouch opposite the chevron manufacturing pouch seal. The Recalling Firm is instructing customer to: -immediate visual inspection of the pouch be conducted (Letter A shown in the red outline opposite the chevron seal [Letter B] in Figure 1) and observe for an open seal (example photographs are included in the Notification). Any product exhibiting an open seal is to be quarantined, and then returned to the Recalling Firm. Customers are to contact their authorized distributor for RMA and shipping instructions. The Recalling Firm requests the following actions be performed to visually inspect the product packaging: 1. Carefully open the Distraction Screw box only on one (1) end, ensuring box integrity. 2. Remove the five (5) sterile pouches. 3. Visually inspect the seal zone (indicated as letter A in Figure 1) opposite the chevron seal (Letter B) for each sterile pouch. 4. IF the pouch is not sealed, DO NOT USE THE DEVICE. Quarantine the device and contact your authorized distributor who will assist you with shipping instructions and replacements. See contact information below. 5. IF the pouch is sealed, is not opened, the product remains sterile and may be used. 6. Complete and return to TSI the enclosed FIELD SAFETY NOTICE ACKNOWLEDGMENT via fax or e-mail. Please complete as soon as possible but no later than July 6, 2020. Contact Information for Returns - RMA: Account Management Telephone 713-726-0886 Email Address acctmgmt@tedansurgical.com Fax 713-726-0846 For further questions, contact Lynne Davies, ldavies@tedansurgical.com or call 713-554-2130
- Quantity
- 495 screws (packaged into 99 boxes) - [5 screws per box]
- Distribution
- Worldwide distribution - U.S. Nationwide distribution including in the states of: AZ, CA, FL, GA, HI, IL, MA, MI, NC, NH, NJ, NY, NV, PA, PR, TN, TX, and WA . The countries of Australia, Canada, France, Philippines, Taiwan, U.A.E., and United Kingdom.
- Lot, serial or model codes
- Product Code: DS-0024 UDI Number: 00851797006481 Lot Number: 2018071601
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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