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Terminated

SC-AcuFix Core Instruments Surgical Techniques covering SC-AcuFix SlimLine, SlimLine Hybrid, Corpectomy, ThinLine and Ant-Cer Anterior Cervical Plating Systems.

FDA Recall Z-0292-06 · Posted 2005-12-17

Recalling FirmAbbott Spine
Recall StatusTerminated
Product CodeKWQ
Date Initiated2005-11-14
Date Terminated2007-10-02
Product QuantityApproximately 941 SC-AcuFix Core Instruments Surgical Techniques

Reason for Recall

Modification to labeling for surgical implant.

Firm Action

Firm contact of Sales Agencies by phone began on 11/11/05 to inform of changes to Surgical Techniques. Letter to surgeons using SC-AcuFix Systems as of 06/01/05 sent 11/14/05.

Root Cause

Other

Distribution Pattern

Nationwide. Surgical Techniques for the SC-AcuFix Anterior Cervical Plating Systems distributed to Sales Agencies and surgeons throughout the U.S.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K024326SPINAL CONCEPTS, INC. ANT-CER DYNAMIC ANTERIOR CERVICAL PLATE SYSTEMSpinal Concepts, Inc. · 2003-01-23K013979SC-ACUFIX THINLINE ANTERIOR CERVICAL PLATE SYSTEMSpinal Concepts, Inc. · 2002-02-13K990005SPINAL CONCEPTS, INC. (SCI) ANTERIOR CERVICAL PLATE SYSTEMSpinal Concepts, Inc. · 1999-02-12

Official Source

View FDA Recall →

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

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