Reported Sep 5, 2012 · Terminated
Apelo Modular Screwdriver labeled in part: "APELO PEDICLE SCREW SYSTEM***Modular Screwdriver***Atlas Spine,…
Atlas Spine, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Atlas Spine, Inc. · 1555 Jupiter Park Dr Ste 4 · Jupiter, FL · 33458-8085
Is this the product you have?
- 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
- DateXX/XX/XXXX***Lot #: XXXX***Weldment***MFG
- Date03/23/2009***Sleeve Assembly***MFG
- DateXX/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
- Lot codes and dates
- PN# 70175-001 CAT#2006-41-0000 Lot # 00686
- Amount recalled
- 4 pieces
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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