Device product
TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only
Z-0488-2026
Product summary
- Event
- Event 97703
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 63 units
- Official record key
device-enforcement:Z-0488-2026
Official wording
Reason: Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position.
Code information: UDI: 07613327626551,07613327626568,07613327626575,07613327626605,07613327627749 07613327627848/ Lot #s: 2410301062 2306091054 2312121078 2401181023 2401231058 2403191046 2404291064 2405021079 2407221023 2407241032 2408081047 2408131037 2408161043 2409031033 2409241016 2410011097 2410071065 2410091014 2410111030 2410291062 2411111012 2411121044 2411201015 2412061031 2412121062 2412201009 2501021011
Distribution pattern: US: IL, OR, MS, TX, OK, UT, MA, MD, NY, PA, VA, FL, CA, MN, GA OUS: Canada, Spain, Brazil,
Derived failure modes
-
Unknown
Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position.