Recall Z-0403-2021
Synthes (USA) Products LLC · initiated September 21, 2020
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
DePuy Synthes SYNMESH 10MM DIA 18MM HEIGHT (TI) Product Number: 495.344 - 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.
Codes / lots: Lot Numbers: H651313 H667046 M22
Reason for recall
Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
FDA-determined cause: Unknown/Undetermined by firm
Action taken
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
Details
- Recall number
- Z-0403-2021
- Initiated
- September 21, 2020
- Terminated
- December 30, 2022
- Product code
- MQP – Spinal Vertebral Body Replacement Device
- Quantity
- 10 units
- Distribution
- International distribution the country of Japan Only.
- Recalling firm
- Synthes (USA) Products LLC, West Chester, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0404-2021 Class III | SYNMESH 12MM DIA 88MM HEIGHT (TI) Product Number: 495.357 - Product Usage: is a…Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM… | 09/21/2020Terminated |
| Z-0405-2021 Class III | SYNMESH 15MM DIA 88MM HEIGHT (TI) Product Number: 495.366 - Product Usage: is a…Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM… | 09/21/2020Terminated |
| Z-0406-2021 Class III | SYNMESH 17MM X 22MM 88MM HEIGHT (TI) Product Number: 495-374 - Product Usage: is a…Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM… | 09/21/2020Terminated |
| Z-0407-2021 Class III | SYNMESH 22MM X 28MM 88MM HEIGHT (TI) Product Number: 495.379 - Product Usage: is a…Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM… | 09/21/2020Terminated |
| Z-0408-2021 Class III | END RING 10MM DIA/0 DEG (TI) Product Number: 495.384 - Product Usage: is a vertebral…Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM… | 09/21/2020Terminated |
| Z-0409-2021 Class III | END RING 12MM DIA/0 DEG (TI) Product Number: 495.385 - Product Usage: is a vertebral…Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM… | 09/21/2020Terminated |
| Z-0410-2021 Class III | END RING 15MM DIA/0 DEG (TI) Product Number: 495.386 - Product Usage: is a vertebral…Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM… | 09/21/2020Terminated |
| Z-0411-2021 Class III | END RING 17MM X 22MM LATERAL OR ANTERIOR/0 DEG (TI) Product Number: 495.392 - Product…Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM… | 09/21/2020Terminated |
| Z-0412-2021 Class III | END RING 17MM X 22MM LATERAL OR ANTERIOR/5 DEG (TI) Product Number: 495.394 - Product…Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM… | 09/21/2020Terminated |
| Z-0413-2021 Class III | END RING 22MM X 28MM LATERAL OR ANTERIOR/0 DEG (TI) Product Number: 495-396 - Product…Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM… | 09/21/2020Terminated |
| Z-0414-2021 Class III | END RING 22MM X 28MM LATERAL OR ANTERIOR/5 DEG (TI) Product Number: 495-398 - Product…Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM… | 09/21/2020Terminated |
| Z-0415-2021 Class III | STANDARD RING 17MM X 22MM (TI) Product Number: 495-405 - Product Usage: is a vertebral…Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM… | 09/21/2020Terminated |
| Z-0416-2021 Class III | STANDARD RING 22MM X 28MM (TI) Product Number: 495-406 - Product Usage: is a vertebral…Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM… | 09/21/2020Terminated |
| Z-0417-2021 Class III | 3.0MM LOCKING SCREW LOW PROFILE (TI) Product Number: 495-491 - Product Usage: is a…Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM… | 09/21/2020Terminated |