Recall Z-0417-2021 ยท MQP Spinal Vertebral Body Replacement Device
Synthes (USA) Products LLC
3.0MM LOCKING SCREW LOW PROFILE (TI) Product Number: 495-491 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the patient s individual pathology and anatomy. The mesh may also be trimmed for a custom fit. The implants can be
| Date | Sep 21, 2020 |
| Status | Terminated |
| Reason | Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device" |
| Root cause | Unknown/Undetermined by firm |
| Action | Synthes GMBH is reporting Recall of SYNMESH CAGE SYSTEM Japan-Specific Country Label Issue . The Japan affiliate will be administering the recall per their local regulations, the week of September 21, 2020. Affiliate will notify Japanese sales representatives. Japanese sales representatives will hand-deliver notices to affected hospitals / surgeons. The Japan affiliate is responsible for managing the rework process. Returned devices will be reworked with correct Japan-specific labels and revised lots |
| Quantity | 18 units |
| Distribution | International distribution the country of Japan Only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041389 | SYNTHES CONTOURED SYNMESH SPACER Synthes Spine, Oct 1, 2004 |