Synthes (USA) Products LLC: Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"

Agency Publication Date: November 5, 2020

Affected Products

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.

Lot Numbers: H651313 H667046 M22

Lot Numbers:

Numbers

Product: SYNMESH 12MM DIA 88MM HEIGHT (TI) Product Number: 495.357 - 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.

Lot Numbers: 15L4249 50P8888 M22

Lot Numbers:

Numbers

Product: SYNMESH 15MM DIA 88MM HEIGHT (TI) Product Number: 495.366 - 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.

Lot Numbers: 16L1245 16L7630 42P1145 42P4281 M22

Lot Numbers:

Numbers

Product: SYNMESH 17MM X 22MM 88MM HEIGHT (TI) Product Number: 495-374 - 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.

Lot Numbers: 16L4528 23P3905 49P1859 M22

Lot Numbers:

Numbers

Product: SYNMESH¿ 22MM X 28MM 88MM HEIGHT (TI) Product Number: 495.379 - 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.

Lot Numbers: 10L8490 17P3848 M22

Lot Numbers:

Numbers

Product: END RING 10MM DIA/0 DEG (TI) Product Number: 495.384 - 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.

Lot Numbers: 10L6451 13L9584

Lot Numbers:

Numbers

Product: END RING 12MM DIA/0 DEG (TI) Product Number: 495.385 - 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.

Lot Numbers: 20P5299 20P5316 20P5321 35P3361 H861583

Lot Numbers:

Numbers

Product: END RING 15MM DIA/0 DEG (TI) Product Number: 495.386 - 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.

Lot Numbers: 13L9586 35P3375 50P2547 H861587

Lot Numbers:

Numbers

Product: END RING 17MM X 22MM LATERAL OR ANTERIOR/0 DEG (TI) Product Number: 495.392 - 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.

Lot Numbers: 43P3070 45P9029 48P09506 H873508

Lot Numbers:

Numbers

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 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.

Lot Numbers: 21P9197 47P8462

Lot Numbers:

Numbers

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.

Lot Numbers: 17P4887 32P3937

Lot Numbers:

Numbers

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.

Lot Numbers: 13L6742 14L2479

Lot Numbers:

Numbers

Product: STANDARD RING 17MM X 22MM (TI) Product Number: 495-405 - 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.

Lot Numbers: 25P6483 3L27511

Lot Numbers:

Numbers

Product: STANDARD RING 22MM X 28MM (TI) Product Number: 495-406 - 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.

Lot Numbers: 19P7847 20P1747 21P3268 H865134

Lot Numbers:

Numbers

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 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.

Lot Numbers: 13L2504 M22

Lot Numbers:

Numbers

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86545

Status: Resolved

Manufacturer: Synthes (USA) Products LLC

Manufactured In: United States

Units Affected: 15 products (10 units; 12 units; 17 units; 9 units; 5 units; 16 units; 18 units; 23 units; 9 units; 4 units; 6 units; 4 units; 7 units; 6 units; 18 units)

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Lot Numbers: H651313 H667046 M22

Lot Numbers:

Numbers

Lot Numbers: 15L4249 50P8888 M22

Lot Numbers:

Numbers

Lot Numbers: 16L1245 16L7630 42P1145 42P4281 M22

Lot Numbers:

Numbers

Lot Numbers: 16L4528 23P3905 49P1859 M22

Lot Numbers:

Numbers

Lot Numbers: 10L8490 17P3848 M22

Lot Numbers:

Numbers

Lot Numbers: 10L6451 13L9584

Lot Numbers:

Numbers

Lot Numbers: 20P5299 20P5316 20P5321 35P3361 H861583

Lot Numbers:

Numbers

Lot Numbers: 13L9586 35P3375 50P2547 H861587

Lot Numbers:

Numbers

Lot Numbers: 43P3070 45P9029 48P09506 H873508

Lot Numbers:

Numbers

Lot Numbers: 21P9197 47P8462

Lot Numbers:

Numbers

Lot Numbers: 17P4887 32P3937

Lot Numbers:

Numbers

Lot Numbers: 13L6742 14L2479

Lot Numbers:

Numbers

Lot Numbers: 25P6483 3L27511

Lot Numbers:

Numbers

Lot Numbers: 19P7847 20P1747 21P3268 H865134

Lot Numbers:

Numbers

Lot Numbers: 13L2504 M22

Lot Numbers:

Numbers

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86545

Status: Resolved

Manufacturer: Synthes (USA) Products LLC

Manufactured In: United States

Units Affected: 15 products (10 units; 12 units; 17 units; 9 units; 5 units; 16 units; 18 units; 23 units; 9 units; 4 units; 6 units; 4 units; 7 units; 6 units; 18 units)