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Terminated

SC-AcuFix Thinline Low-Profile Anterior Cervical Plate System manufactured by Spinal Concepts, Inc., An Abbott Laboratories Company, Austin, Texas

FDA Recall Z-0880-05 · Posted 2005-06-11

Recalling FirmSpinal Concepts, Inc
Recall StatusTerminated
Product CodeKWQ
Date Initiated2002-07-01
Date Terminated2005-12-20
Product Quantity10 systems

Reason for Recall

Complaints were recieved where swivels came out of plate and where the screw went through the plate.

Firm Action

The firm initiated the recall via telephone communication from sales representatives around August 2002.

Root Cause

Other

Distribution Pattern

Systems were distributed to hospitals in CA, IL, IN, NC, MS, PA, NY and VA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K013979SC-ACUFIX THINLINE ANTERIOR CERVICAL PLATE SYSTEMSpinal Concepts, Inc. · 2002-02-13

Official Source

View FDA Recall →

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

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