TeDan Surgical Innovations LLC PHANTOM CS DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
PHANTOM CS DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
Brand
TeDan Surgical Innovations LLC
Lot Codes / Batch Numbers
Product Code: DS-0012 UDI Number: 00851797006443 Lot Number: 2018021901 2018061101
Products Sold
Product Code: DS-0012 UDI Number: 00851797006443 Lot Number: 2018021901 2018061101
TeDan Surgical Innovations LLC is recalling PHANTOM CS DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distrac due to Lack of pouch seal. Product is labelled as sterile.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Lack of pouch seal. Product is labelled as sterile.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026