Recall Z-1964-2017— The Anspach Effort, Inc.

Name: FDA recall Z-1964-2017
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: K955084. Product: ADJUSTABLE DRILL GUIDE, 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

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

ADJUSTABLE DRILL GUIDE, 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.