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Terminated

Orthofix rotating cutter used in spinal fusion procedures with the FORZA Spacer System. Catalog Number 89-0452 (8mm Rotating Cutter), 89-0454 (10mm Rotating Cutter), and 89-0030 (FORZA Discectomy Case). Manual surgical instrument comprised of stainless steel and titanium.

FDA Recall Z-1037-2012 · Posted 2012-02-15

Recalling FirmOrthofix, Inc.
Recall StatusTerminated
Product Codemax
Date Initiated2012-02-06
Date Terminated2012-06-11
Product Quantity52

Reason for Recall

The 8mm and 10mm Rotating Cutters may fracture during use, specifically during disc space preparation. If an 8mm or 10mm Rotating Cutter does Fracture during use, it may result in a surgical delay estimated to be 30 minutes or greater due to preparing the disc space using other instruments or methods and/or retrieving the instrument fragment.

Firm Action

Orthofix mailed recall letters to the distributors on 02/06/2012. Orthofix does not sell or consign these instruments to hospitals.

Root Cause

Device Design

Distribution Pattern

Nationwide and Puerto Rico

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K103111FORZA SPACER SYSTEMOrthofix, Inc. · 2011-03-23

Official Source

View FDA Recall →

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

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