—#184029

Product

END RING 22MM X 28MM LATERAL OR ANTERIOR/5 DEG (TI) Product Number: 495-398 - 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 inserted anteriorly, laterally or anterolaterally.

FDA product code: MQP — Spinal Vertebral Body Replacement Device
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K003275, K983766
Affected lot / code info: Lot Numbers: 13L6742 14L2479

Why it was recalled

Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"

Root cause (FDA determination)

Unknown/Undetermined by firm

Action the firm took

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

Recalling firm

Firm: Synthes (USA) Products LLC
Address: 1301 Goshen Pkwy, West Chester, Pennsylvania 19380-5986

Distribution

Distribution pattern: International distribution the country of Japan Only.

Timeline

Recall initiated: 2020-09-21
Terminated: 2022-12-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #184029. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.