FDA Device recall Z-0488-2026
TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only
- FDA Device
- Class I
- ongoing
- Published 2025-11-26
On 2025-11-26 the FDA classified a Class I recall of TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only by Tmj Solutions, citing patient-fitted temporomandibular joint implant contained discrepancy in screw hole position.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0488-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-10-13 |
| Published | 2025-11-26 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Tmj Solutions |
| Distribution | CA, FL, GA, IL, MA, MD, MN, MS, NY, OK, OR, PA, TX, UT, VA |
Product
TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only
Reason
Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position.
Identifiers
| code_info | UDI: 07613327626551,07613327626568,07613327626575,07613327626605,07613327627749 07613327627848/ Lot #s: 2410301062 2306…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0488-2026%22
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