Apelo Modular Screwdriver labeled in part: "APELO PEDICLE SCREW SYSTEMModular ScrewdriverAtlas Spine, Inc.www.AtlasSpine.com 1555 Jupiter Park Drive #4Jupiter, Florida 33458561-741-1108Tissue SleeveMFG Date: XX/XX/XXXXLot #: XXXXWeldmentMFG Date: 03/23/2009Sleeve AssemblyMFG Date: XX/XX/XXXXLot #: XXXXQty: 1 Rx OnlyNon-Sterile. Sterilize Prior to Use* Rev. A*. The Modular Screwdriver is used to insert modular pedicle screw implants which are

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. I…

Recall #: Z-2274-2012
Affected scope: 4 pieces
Initiated: June 4, 2009

Compiled from official public sources by the publisher. · Updated September 2026

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Atlas Spine, Inc. recalled Apelo Modular Screwdriver labeled in part: "APELO PEDICLE SCREW SYSTEM***Modular Screwdri… - a moderate-severity action.

Apelo Modular Screwdriver labeled in part: "APELO PEDICLE SCREW SYSTEM***Modular Screwdri… was recalled by Atlas Spine, Inc. in September 5, 2012. Reason: Atlas Spine, Inc. recalled their Apelo Modular Screwdriver, a component of the Apelo Pedicle Screw System Ins…. Check the official notice for the remedy. Verify recall #Z-2274-2012 with the FDA Devices before acting.

The recall

Atlas Spine, Inc. issued this moderate-severity FDA Devices recall-Atlas Spine, Inc. recalled their Apelo Modular Screwdriver, a component of the Apelo Pedicle Screw System Ins….

Moderate
severity level: Class II
classification: September 5, 2012
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-2274-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

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.

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.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-2274-2012
Date reported	September 5, 2012
Date initiated	June 4, 2009
Recalling firm	Atlas Spine, Inc.
Firm location	Jupiter, FL
Affected scope	4 pieces
Distribution	USA Distribution to the state of Florida only.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

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Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on September 5, 2012. Severity: Moderate. Recall number: Z-2274-2012.

Where was the recalled product distributed? ▼

Distribution: USA Distribution to the state of Florida only..

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

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Similar severity · nearest report date

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This recall: FDA Devices, reported September 5, 2012. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026