Atlas Spine, Inc. 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Atlas Spine, Inc.
Lot Codes / Batch Numbers
PN# 70175-001 CAT#2006-41-0000 Lot # 00686
Products Sold
PN# 70175-001 CAT#2006-41-0000 Lot # 00686
Atlas Spine, Inc. is recalling Apelo Modular Screwdriver labeled in part: "APELO PEDICLE SCREW SYSTEM***Modular Screwdriver***Atlas due to Atlas Spine, Inc. recalled their Apelo Modular Screwdriver, a component of the Apelo Pedicle Screw System Instrumentation, because of complaints recei. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Consignees were notified by Telephone and visit. All products will be returned, quarantined and then destroyed.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
FL
Page updated: Jan 10, 2026