Atlas Spine, Inc.: Medical Device Recall in 2012 - (Recall #: Z-2274-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: June 4, 2009

Date Posted: September 5, 2012

Recall Number: Z-2274-2012

Event ID: 62564

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.

Status: Terminated

Product Quantity: 4 pieces

Code Information:

PN# 70175-001 CAT#2006-41-0000 Lot # 00686

Distribution Pattern:

USA Distribution to the state of Florida only.

Voluntary or Mandated:

Voluntary: Firm initiated