3COR DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
Recall
- Recall Number
- Z-2525-2020
- Event Number
- 85830
- Firm
- TeDan Surgical Innovations LLC
- FEI Number
- 3005726885
- Product Code
- LXH
- Status
- Terminated
- Root Cause
- Packaging change control
- Initiated
- May 15, 2020
- Terminated
- September 8, 2022
- Address
- 12615 W Airport Blvd, Ste 200, Sugar Land, TX, 77478-6203
Description
3COR DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
Lack of pouch seal. Product is labelled as sterile.
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 [email protected] Fax 713-726-0846 For further questions, contact Lynne Davies, [email protected] or call 713-554-2130
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.
1935 screws (packaged into 387 boxes) - [5 screws per box]