Recall Z-1841-2016— Integra York PA, Inc

Name: FDA recall Z-1841-2016
Creator: U.S. Food and Drug Administration
Published: 2016-03-11

Class II · Terminated

Class II FDA medical device recall by Integra York PA, Inc, initiated 2016-03-11, terminated 2017-04-17. FDA's recall record names no specific 510(k) clearance for this event. Product: Miltex Premium Grade Self-Lock Chisel Blade Handle, Catalogue No. 4-405, manual surgical instrument.. Reason: One lot of self-lock chisel blade handles have a wider slot that holds the chisel blade that may result in the inability to firmly secure the blade in the handle..

Recalling firm: Integra York PA, Inc
Classification: Class II
Status: Terminated
Initiated: 2016-03-11
Terminated: 2017-04-17
Firm location: York, PA, United States

Product description

Miltex Premium Grade Self-Lock Chisel Blade Handle, Catalogue No. 4-405, manual surgical instrument.

Reason for recall

One lot of self-lock chisel blade handles have a wider slot that holds the chisel blade that may result in the inability to firmly secure the blade in the handle.

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