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Z-2501-2020 Class II

Recalled by CTL Medical Corporation — Addison, TX

FDA device recall Z-2501-2020 was initiated by CTL Medical Corporation on Aug 21, 2019 and is designated Class II. Reason for recall: Reports received of the device fracturing during insertion. Affected quantity: 39 units.

Recall details

Product Type: Devices
Report Date: Jul 15, 2020
Initiation Date: Aug 21, 2019
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 39 units

Product description

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

Reason for recall

Reports received of the device fracturing during insertion.

Distribution pattern

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

Code information

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

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-2501-2020
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Other recalls by CTL Medical Corporation

Z-2504-2020 Class II — CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H8mm, Part #018.1908. (Aug 21, 2019)
Z-2503-2020 Class II — CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H8mm, Part #018.1308. (Aug 21, 2019)
Z-2502-2020 Class II — CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H7mm, Part #018.1907. (Aug 21, 2019)
Z-1030-2019 Class II — CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref 015.7050 (Jul 5, 2018)
Z-1031-2019 Class II — CTL Medical Hex Driver MIS, 1/4" Square QC, 4.0 Ratcheting Ref 019.7050 (Jul 5, 2018)