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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85218

4 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 21, 2019
Product types
Device
Classifications
Class II
Statuses
Completed
Recalling firm wording
CTL Medical Corporation

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

4 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 4

CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H7mm, Part #018.1307.

Z-2501-2020
Recall number
Z-2501-2020
Initiated
August 21, 2019
Classification
Class II
Status
Completed
Recalling firm
CTL Medical Corporation
Quantity
39 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reports received of the device fracturing during insertion.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reports received of the device fracturing during insertion.

Code information

Lot numbers 14LDDOCB, 15CNDOBC, 15DIDOCC, and 7FGAD.

Distribution pattern

Distribution was made to AZ, FL, IN, KS, MA, MI, NY, TN, and TX.

device · product 2 of 4

CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H7mm, Part #018.1907.

Z-2502-2020
Recall number
Z-2502-2020
Initiated
August 21, 2019
Classification
Class II
Status
Completed
Recalling firm
CTL Medical Corporation
Quantity
39 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reports received of the device fracturing during insertion.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reports received of the device fracturing during insertion.

Code information

Lot numbers 14LEDODB, 15CNDOGC, and 15DJDOEC .

Distribution pattern

Distribution was made to AZ, FL, IN, KS, MA, MI, NY, TN, and TX.

device · product 3 of 4

CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H8mm, Part #018.1308.

Z-2503-2020
Recall number
Z-2503-2020
Initiated
August 21, 2019
Classification
Class II
Status
Completed
Recalling firm
CTL Medical Corporation
Quantity
45 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reports received of the device fracturing during insertion.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reports received of the device fracturing during insertion.

Code information

Lot numbers 14LEDOAB, 15CNDOCC, 15DIDOBC, and 7FGBD.

Distribution pattern

Distribution was made to AZ, FL, IN, KS, MA, MI, NY, TN, and TX.

device · product 4 of 4

CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H8mm, Part #018.1908.

Z-2504-2020
Recall number
Z-2504-2020
Initiated
August 21, 2019
Classification
Class II
Status
Completed
Recalling firm
CTL Medical Corporation
Quantity
46 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reports received of the device fracturing during insertion.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reports received of the device fracturing during insertion.

Code information

Lot numbers 14LEDOEB, 15CNDOHC, and 15DJDOHC.

Distribution pattern

Distribution was made to AZ, FL, IN, KS, MA, MI, NY, TN, and TX.