Recall Z-1983-2014— The Anspach Effort, Inc.

Name: FDA recall Z-1983-2014
Creator: U.S. Food and Drug Administration
Published: 2014-05-08

Class II · Terminated

Class II FDA medical device recall by The Anspach Effort, Inc., initiated 2014-05-08, terminated 2016-01-29. It names one FDA 510(k) clearance: K955084. Product: Anspach Pneumatic and Electric Motor Systems. Intended for cutting and shaping bone, including the spine and cranium.. Reason: Several attachments and handpieces failed to meet the expected sterility assurance level (SAL) when sterilized by the method that is specified in the current Directions for Use (DFU) provided with the device..

Recalling firm: The Anspach Effort, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-05-08
Terminated: 2016-01-29
Firm location: Palm Beach Gardens, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K955084 — ASPACH 65,000 (MODIFICATION)The Anspach Effort, Inc.·cleared 1996-01-17

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 Pneumatic and Electric Motor Systems. Intended for cutting and shaping bone, including the spine and cranium.

Reason for recall

Several attachments and handpieces failed to meet the expected sterility assurance level (SAL) when sterilized by the method that is specified in the current Directions for Use (DFU) provided with the device.

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