Recall Z-1961-2017— The Anspach Effort, Inc.

Name: FDA recall Z-1961-2017
Creator: U.S. Food and Drug Administration
Published: 2016-10-06

Class II · Terminated

Class II FDA medical device recall by The Anspach Effort, Inc., initiated 2016-10-06, terminated 2019-07-26. It names one FDA 510(k) clearance: K974025. Product: LARGE CRANIOTOME, BLACK MAX. Reason: Supplied Directions for Use (DFU) did not contain a recommended service interval..

Recalling firm: The Anspach Effort, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-10-06
Terminated: 2019-07-26
Firm location: Palm Beach Gardens, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K974025 — ANSPACH SHIELDED ATTACHMENTThe Anspach Effort, Inc.·cleared 1998-07-06

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

LARGE CRANIOTOME, BLACK MAX

Reason for recall

Supplied Directions for Use (DFU) did not contain a recommended service interval.

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