Recall Z-0074-2013— The Anspach Effort, Inc.
Class II · Terminated
Class II FDA medical device recall by The Anspach Effort, Inc., initiated 2012-01-09, terminated 2014-09-16. It names 2 FDA 510(k) clearances: K080802, K011444. Product: "***Electric Systems Foot Control****Rx Only***" Product Usage: Cutting and shaping bone including bones of the spine and cranium.. Reason: 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..
- Recalling firm
- The Anspach Effort, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-01-09
- Terminated
- 2014-09-16
- Firm location
- Palm Beach Gardens, FL, United States
510(k) clearances named in this recall
2 on FDA's record- K080802 — EMAX 2 PLUS SYSTEM, MODEL EMAX 2 PLUS MOTOR, EMAX 2 CONSOLE>FIRMWARE UPGRADE, EMAX 2 FP FOOT PEDAL
- K011444 — ANSPACH EMAX DRILL SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
"***Electric Systems Foot Control****Rx Only***" Product Usage: Cutting and shaping bone including bones of the spine and cranium.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.