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Terminated

Apelo Modular Screwdriver labeled in part: "APELO PEDICLE SCREW SYSTEM***Modular Screwdriver***Atlas Spine, Inc.***www.AtlasSpine.com*** 1555 Jupiter Park Drive #4***Jupiter, Florida 33458***561-741-1108***Tissue Sleeve***MFG Date: XX/XX/XXXX***Lot #: XXXX***Weldment***MFG Date: 03/23/2009***Sleeve Assembly***MFG Date: XX/XX/XXXX***Lot #: XXXX***Qty: 1 Rx Only***Non-Sterile. Sterilize Prior to Use*** Rev. A***. The Modular Screwdriver is used to insert modular pedicle screw implants which are part of the Apelo System.

FDA Recall Z-2274-2012 · Posted 2012-08-27

Recalling FirmAtlas Spine, Inc.
Recall StatusTerminated
Product CodeNKB
Date Initiated2009-06-04
Date Terminated2014-07-16
Product Quantity4 pieces

Reason for Recall

Atlas Spine, Inc. recalled their Apelo Modular Screwdriver, a component of the Apelo Pedicle Screw System Instrumentation, because of complaints received about the tip breaking. If the tip is fractured inside of the modular screw, the tip could become implanted in the body or if the entire screw is removed, it could cause a delay in the surgery.

Firm Action

Consignees were notified by Telephone and visit. All products will be returned, quarantined and then destroyed.

Root Cause

Component design/selection

Distribution Pattern

USA Distribution to the state of Florida only.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K072426ATLAS SPINE PEDICLE SCREW SYSTEMAtlas Spine, LLC · 2007-10-19

Official Source

View FDA Recall →

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

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