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Completed

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

FDA Recall Z-2504-2020 · Posted None

Recalling FirmCTL Medical Corporation
Recall StatusCompleted
Product CodeMAX
Date Initiated2019-08-21
Product Quantity46 units

Reason for Recall

Reports received of the device fracturing during insertion.

Firm Action

The recalling firm issued letters dated 8/21/2019 to all distributors or CTL representatives via email beginning 8/21/2019 with a follow-up hard copy of the correspondence being issued via FedEx. The devices were to be returned.

Root Cause

Device Design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K131981CEZANNE II INTERBODY FUSION SYSTEMAccel Spine · 2013-10-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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