Recall Z-2524-2020 ยท LXH Orthopedic Manual Surgical Instrument
TeDan Surgical Innovations LLC
3COR DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
| Date | May 15, 2020 |
| Status | Terminated |
| 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 |
| Quantity | 2735 individual screws (packaged into 547 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.