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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97703

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 13, 2025
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
TMJ Solutions Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only

Z-0488-2026
Recall number
Z-0488-2026
Initiated
October 13, 2025
Classification
Class I
Status
Ongoing
Recalling firm
TMJ Solutions Inc
Quantity
63 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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,