Synthes SynMesh Cage System Recalled for Incorrect Labeling
Synthes (USA) Products LLC is recalling 4 units of the SynMesh Cage System because the statutory label incorrectly stated 'general medical device' instead of 'specially controlled medical device'.
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 4 units of the END RING 17MM X 22MM LATERAL OR ANTERIOR/5 DEG (TI) (Product Number: 495.394), part of the SynMesh Cage System. The recall is due to a labeling error where the statutory label printed 'general medical device' instead of the correct classification 'specially controlled medical device'.
The affected units are identified by Lot Numbers 21P9197 and 47P8462. These devices are vertebral body replacement implants used in the cervical, thoracic, and lumbar spine. The distribution 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. Consumers and healthcare providers should verify the labeling on their devices and contact the manufacturer for further instructions.
The recalled product
- Product
- END RING 17MM X 22MM LATERAL OR ANTERIOR/5 DEG (TI) Product Number: 495.394 - 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 th
- Manufacturer
- Synthes (USA) Products LLC
- Category
- Medical Device — Spinal Implant
- Hazard
- Affected units
- 4
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: 21P9197 47P8462
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