"***Electric Systems Foot Control with Direction and Irrigation***Rx Only***" Product Usage: Cutting and shaping bone in
FDA device recall Z-0076-2013 · posted 2012-10-18 · Terminated
Recall details
- Recalling firm
- The Anspach Effort, Inc.
- Reason for recall
- The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling the foot control/foot pedal due to the Foot Control Cable lacking the shield connection from the cable to the connector body.
- Action taken
- Anspach sent an Urgent Product Removal letter dated January 9, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to contact their sales representative to facilitate the removal action by providing a replacement for the affected product. For question contact your local sales representative or the Product Support department.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- HBE
- Quantity affected
- 10 units
- Distribution
- Worldwide Distribution - US (nationwide) and the countries of: Italy, Japan, Switzerland, Turkey and Taiwan.
- Date initiated
- 2012-01-09
- Date posted
- 2012-10-18
- Date terminated
- 2014-09-16
- Location
- Palm Beach Gardens, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EMAX 2 PLUS SYSTEM, MODEL EMAX 2 PLUS MOTOR, EMAX 2 CONSOLE>FIRMWARE UPGRADE, EMAX 2 FP FOOT PEDAL (K080802) | The Anspach Effort, Inc. | 2008-04-30 |
| ANSPACH EMAX DRILL SYSTEM (K011444) | The Anspach Effort, Inc. | 2001-08-08 |