Reported Nov 11, 2020 · Terminated
DePuy Synthes SYNMESH 10MM DIA 18MM HEIGHT (TI) Product Number: 495.344 - Product Usage: is a vertebral body…
Synthes (USA) Products LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Synthes (USA) Products LLC · 1301 Goshen Pkwy · West Chester, PA · 19380-5986
Is this the product you have?
- DePuy Synthes SYNMESH 10MM
- DIA 18MM HEIGHT (TI) Product Number495.344 -
- Product Usageis 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 codes and dates
- Lot NumbersH651313 H667046 M22
- Amount recalled
- 10 units
This recall covers 15 products
The agency filed one notice per product. You are reading one of them; the other 14 are below.
2 more are in the archive.
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"
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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