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Terminated

Zimmer / Abbott Spine Sequoia dorsal height & revision tool, non-sterile; REF 3367-1. Surgical instrument for pedicle screw system.

FDA Recall Z-0554-2010 · Posted 2009-12-22

Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeNKB
Date Initiated2009-08-20
Date Terminated2011-04-13
Product Quantity215

Reason for Recall

The tip of the instrument may fracture during use.

Firm Action

Zimmer sent a letter dated 8/17/09 to distributors and consignees on or about 8/20/09. Users were notified of the potential problem via the letter and advised that the instruments will be removed and replaced when a new version of the instrument becomes available (around 10/09).

Root Cause

Device Design

Distribution Pattern

Nationwide, Belgium and New Zealand.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K082032SEQUOIA SPINAL SYSTEM (MODEL 3306), SPEEDLINK TRANSVERSE CONNECTOR (MODELS 3308, 3309, 3310)Abbott Spine, Inc. · 2008-10-06

Official Source

View FDA Recall →

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

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