Synthes SynMesh Cages Recalled for Incorrect Statutory Labeling
Synthes (USA) Products LLC is recalling 18 units of SynMesh Cages due to incorrect statutory labeling. The devices were distributed only in Japan.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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. The issue is a minor labeling error regarding the statutory device classification.
Plain-English summary
Synthes (USA) Products LLC is recalling 18 units of the 3.0MM Locking Screw Low Profile (TI) (Product Number 495-491), part of the SynMesh Cage System. The recall is due to a labeling error where the statutory label incorrectly printed 'general medical device' instead of 'specially controlled medical device.'
The affected units are identified by Lot Numbers 13L2504 and M22. These devices are vertebral body replacement implants used for the cervical, thoracic, and lumbar spine. The distribution was limited to Japan.
No specific consumer actions are detailed in the source text beyond the recall notification. The hazard is administrative, relating to the classification label on the device packaging.
The recalled product
- Product
- 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…
- Manufacturer
- Synthes (USA) Products LLC
- Hazard
- Affected units
- 18
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: 13L2504 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.
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