Recall Z-2253-2016— The Anspach Effort, Inc.

Name: FDA recall Z-2253-2016
Creator: U.S. Food and Drug Administration
Published: 2016-06-15

Class II · Terminated

Class II FDA medical device recall by The Anspach Effort, Inc., initiated 2016-06-15, terminated 2016-12-14. It names one FDA 510(k) clearance: K133604. Product: Anspach G1 High Speed Electric Handpiece Air Cooled (eG1A) Use for cutting and shaping bone including bones of the cranium and spine.. Reason: The graphics at the attachment interface indicating locked and unlocked position are reversed..

Recalling firm: The Anspach Effort, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-06-15
Terminated: 2016-12-14
Firm location: Palm Beach Gardens, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K133604 — ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTSThe Anspach Effort, Inc.·cleared 2014-01-10

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

Anspach G1 High Speed Electric Handpiece Air Cooled (eG1A) Use for cutting and shaping bone including bones of the cranium and spine.

Reason for recall

The graphics at the attachment interface indicating locked and unlocked position are reversed.

Data sourced from openFDA. This site is unofficial and independent of the FDA.