Recall Z-2021-2017— The Anspach Effort, Inc.

Class II · Terminated

Class II FDA medical device recall by The Anspach Effort, Inc., initiated 2016-10-06, terminated 2019-07-26. FDA's recall record names no specific 510(k) clearance for this event. Product: 10.5cm QD Angle Attachment Product Usage: Pneumatic system. 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

Product description

10.5cm QD Angle Attachment Product Usage: Pneumatic system

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.