Z-0413-2021Class III
END RING 22MM X 28MM LATERAL OR ANTERIOR/0 DEG (TI) Product Number: 495-396 -
Synthes (USA) Products LLC / initiated 2020-09-21 / Terminated / root cause: labeling and UDI
Synthes (USA) Products LLC began a recall of END RING 22MM X 28MM LATERAL OR ANTERIOR/0 DEG (TI) Product Number: 495-396 - Product Usage: is a vertebral body replacement device for the cervical, thoracic... on . FDA classified it as Class III and gives the reason as "Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.
Recall record
- Recall number
- Z-0413-2021
- Classification
- Class III
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Synthes (USA) Products LLC
- Product
- END RING 22MM X 28MM LATERAL OR ANTERIOR/0 DEG (TI) Product Number: 495-396 - 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.
- Product code
- MQP Spinal Vertebral Body Replacement Device
- Reason for recall
- Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
- Root cause tag
- labeling and UDI
- FDA 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 in commerce
- 6 units
- Distribution
- International distribution the country of Japan Only.
- Product codes and lots
- Lot Numbers: 17P4887 32P3937
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0403-2021 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0404-2021 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0405-2021 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0406-2021 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0407-2021 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0408-2021 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0409-2021 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0410-2021 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0411-2021 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0412-2021 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0413-2021 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0414-2021 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0415-2021 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0416-2021 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0417-2021 | Class III | Terminated | Voluntary: Firm initiated |
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