Synthes SYNMesh Vertebral Body Replacement Devices Recalled for Labeling Error
Synthes (USA) Products LLC is recalling 12 units of SYNMesh vertebral body replacement devices because the statutory label incorrectly identifies them as 'general medical devices' instead of 'specially controlled medical devices.'
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, and the issue is a minor labeling error.
Plain-English summary
Synthes (USA) Products LLC is recalling 12 units of SYNMesh 12MM DIA 88MM HEIGHT (TI) vertebral body replacement devices. The recall is due to a labeling error on the statutory label, which incorrectly states 'general medical device' instead of the required 'specially controlled medical device.'
The affected devices are titanium implants used for the cervical, thoracic, and lumbar spine. The specific lot numbers involved are 15L4249, 50P8888, and M22. The distribution pattern for these units was limited to Japan.
This recall is classified as Class III by the FDA, indicating that the labeling error is unlikely to cause adverse health consequences. No injuries or illnesses have been reported in connection with this recall.
The recalled product
- Product
- SYNMESH 12MM DIA 88MM HEIGHT (TI) Product Number: 495.357 - 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
- Manufacturer
- Synthes (USA) Products LLC
- Hazard
- Affected units
- 12
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Numbers: 15L4249 50P8888 M22
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 15 recalled by Synthes (USA) Products LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 15 products in this recall →Related recalls
Same manufacturer · Synthes (USA) Products LLC
See all →- HighVOLT locking screw taps swapped between lots carry incorrect thread
FDA (Devices) · 2026-04-08
- HighVOLT bone taps swapped between lots carry the incorrect thread
FDA (Devices) · 2026-04-08
- ModerateLocking bone screws recalled after packaging labeled with the wrong length
FDA (Devices) · 2025-10-29
- ModerateForty six millimetre locking screws recalled over wrong length on packaging
FDA (Devices) · 2025-10-29
- HighSurgical screwdrivers recalled for failure to engage with implant screws
FDA (Devices) · 2024-06-05
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02