Z-2274-2012Class II

Apelo Modular Screwdriver labeled in part: "APELO PEDICLE SCREW SYSTEMModular ScrewdriverAtlas Spine...

Name: Z-2274-2012 Apelo Modular Screwdriver labeled in part: "APELO PEDICLE SCREW SYSTEM***Modular Screwdriver***Atlas Spine...
Creator: Atlas Spine, Inc.
Published: 2009-06-04
License: https://open.fda.gov/license/

Atlas Spine, Inc. / initiated 2009-06-04 / Terminated / root cause: design

FDA source

Atlas Spine, Inc. began a recall of Apelo Modular Screwdriver labeled in part: "APELO PEDICLE SCREW SYSTEM***Modular Screwdriver***Atlas Spine, Inc.***www.AtlasSpine.com*** 1555 Jupiter Park... on 2009-06-04. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2274-2012
Classification: Class II
Status: Terminated
Initiated: 2009-06-04
Posted: 2012-08-27
Terminated: 2014-07-16
Recalling firm: Atlas Spine, Inc.
Product: 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 code: NKB Thoracolumbosacral Pedicle Screw System
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.
Root cause tag: design
FDA root cause: Component design/selection
Action: Consignees were notified by Telephone and visit. All products will be returned, quarantined and then destroyed.
Quantity in commerce: 4 pieces
Distribution: USA Distribution to the state of Florida only.
Product codes and lots: PN# 70175-001 CAT#2006-41-0000 Lot # 00686

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2274-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2274-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-05	2012-08-27

Product code NKB

K072426Class IIAtlas Spine Pedicle Screw SystemAtlas Spine, LLC / cleared 2007-10-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)