Recall Z-0223-2020 ยท NKG Posterior Cervical Screw System
Synthes (USA) Products LLC
Synapse System 3.5mm TI Cancellous Polyaxial Screws, Part No. 04.615.026 for use in spinal surgery
| Date | Sep 16, 2019 |
| Status | Terminated |
| Reason | The subject product measures 4.0mm in diameter instead of 3.5mm. |
| Root cause | Process control |
| Action | On September 16, 2019, the firm distributed Urgent Medical Device Recall letters to customers, notifying them that the affected screws measure 4.0mm in diameter instead of 3.5mm. Customers should take the following actions: 1. Immediately review your inventory to identify and quarantine the subject product in a manner that ensures the subject product will not be used. 2. Complete the attached Verification Section and return to firm even if you have no product on hand. If you have product to be returned: - Call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number. - |
| Quantity | 6 |
| Distribution | Distributed to NJ. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142838 | Synapse Occipital-Cervical-Thoracic (OCT) System Synthes USA Products, LLC, Jan 20, 2015 |