Apelo Modular Screwdriver labeled in part: "APELO PEDICLE SCREW SYSTEM***Modular Screwdriver***Atlas Spine, Inc.***www.A
FDA device recall Z-2274-2012 · posted 2012-08-27 · Terminated
Recall details
- Recalling firm
- Atlas Spine, Inc.
- 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.
- Action taken
- Consignees were notified by Telephone and visit. All products will be returned, quarantined and then destroyed.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- NKB
- Quantity affected
- 4 pieces
- Distribution
- USA Distribution to the state of Florida only.
- Date initiated
- 2009-06-04
- Date posted
- 2012-08-27
- Date terminated
- 2014-07-16
- Location
- Jupiter, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ATLAS SPINE PEDICLE SCREW SYSTEM (K072426) | Atlas Spine, LLC | 2007-10-19 |