Apelo Modular Screwdriver labeled in recall
Apelo Modular Screwdriver labeled in part: "APELO PEDICLE SCREW SYSTEM***Modular Screwdriver***Atlas Spine, Inc.***www.AtlasSpine.com*** 1555 Jupiter…
Why was Apelo Modular Screwdriver labeled in 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
PN# 70175-001 CAT#2006-41-0000 Lot # 00686
- Product
- Apelo Modular Screwdriver labeled in part: "APELO PEDICLE SCREW SYSTEM***Modular Screwdriver***Atlas Spine, Inc.***www.AtlasSpine.com*** 1555 Jupiter…
- Recalling firm
- Atlas Spine, Inc.
- Quantity
- 4 pieces
- Distribution
- USA Distribution to the state of Florida only.
- Recall date
- September 5, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)