Recall Z-1503-2020 ยท LXH Orthopedic Manual Surgical Instrument
TeDan Surgical Innovations LLC
D-0012 3COR 12MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and the TSI Quick Start Distraction Screws products are intended for the distraction in the anterior approach to the cervical spine from C2 thru C7. The products are to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers.
| Date | Feb 18, 2019 |
| Status | Terminated |
| 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 info |
| Quantity | 49 boxes (245 individual screws) |
| Distribution | Worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.