Synthes END RING Vertebral Implant Labeled Incorrectly - Recall
Synthes recalls END RING 17mm x 22mm spinal implants due to incorrect labeling as a general medical device instead of specially controlled medical device. Affected units have specific product numbers and lot numbers.
Recall notice
Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
Contact the company
What happened, in plain English
Synthes is recalling certain spinal implants because they were incorrectly labeled as a general medical device instead of a specially controlled medical device. This labeling error could lead to improper regulatory oversight and potential safety issues during medical procedures. Read more at govinfonow.com/recall/64239-synthes-end-ring-vertebral-implant-labeled-incorrectly-recall.
Source Summary by GovInfoNow · govinfonow.com/recall/64239-synthes-end-ring-vertebral-implant-labeled-incorrectly-recall · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0412-2021
Cite this page
“Synthes END RING Vertebral Implant Labeled Incorrectly - Recall.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64239-synthes-end-ring-vertebral-implant-labeled-incorrectly-recall. Based on FDA recall #Z-0412-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0412-2021%22&limit=1).
Why it’s dangerous
The implants were labeled incorrectly as a general medical device instead of a specially controlled medical device. This mislabeling could result in improper regulatory oversight and potential safety issues during medical procedures.
Who’s affected
Patients who received the END RING 17mm x 22mm spinal implants with product number 495.394 and lot numbers 21P9197 or 47P8462 are affected. Surgeons and medical facilities using these implants are at risk.
How to tell if you have this one
Check for product number 495.394 and lot numbers 21P9197 or 47P8462 on the implant packaging or device. These are specific spinal implants used for cervical, thoracic, and lumbar spine replacements.
- Brand
Synthes- Category
Medical device
All 15 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Terminated- Distribution
International distribution the country of Japan Only.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0403-2021 | 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 | 10 units |
| Z-0404-2021 | 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 | 12 units |
| Z-0405-2021 | 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 | 17 units |
| Z-0406-2021 | 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 | 9 units |
| Z-0407-2021 | 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 | 5 units |
| Z-0408-2021 | 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 | 16 units |
| Z-0409-2021 | 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 | 18 units |
| Z-0410-2021 | 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 | 23 units |
| Z-0411-2021 | 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 | 9 units |
| Z-0412-2021 | 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 | 4 units |
| Z-0413-2021 | 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 | 6 units |
| Z-0414-2021 | 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 | 4 units |
| Z-0415-2021 | 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 | 7 units |
| Z-0416-2021 | 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 | 6 units |
| Z-0417-2021 | 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 | 18 units |
What to do — step by step
Check Product Label
Look for product number 495.394 and lot numbers 21P9197 or 47P8462 on the implant packaging or device.
How this recall unfolded
Recall timeline
FDA terminated this recall 2.3 years after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0412-2021 (September 21, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0412-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.