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Class 2 Device Recall TSI Distraction Screw |
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| Date Initiated by Firm |
May 15, 2020 |
| Create Date |
July 10, 2020 |
| Recall Status1 |
Terminated 3 on September 08, 2022 |
| Recall Number |
Z-2525-2020 |
| Recall Event ID |
85830 |
| Product Classification |
Orthopedic manual surgical instrument - Product Code LXH
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| Product |
3COR DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine. |
| Code Information |
Product Code: D-0014 UDI Number: 00843059121742 Lot Number: 2018020801 2018080601 |
Recalling Firm/
Manufacturer |
TeDan Surgical Innovations LLC
12615 W Airport Blvd Ste 200
Sugar Land TX 77478-6203
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| For Additional Information Contact |
Danny Fishman
713-726-0886
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Manufacturer Reason
for Recall |
Lack of pouch seal. Product is labelled as sterile.
|
FDA Determined
Cause 2 |
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 in Commerce |
1935 screws (packaged into 387 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. |
| Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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