Integra York PA, Inc recalls Miltex Premium Grade Self-Lock Chisel Blade Handle, Catalogue No. 4-405, manual surgical instrument.

Recall date

March 11, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1841-2016

FDA classification

Class II

Brand / firm

Integra York PA, Inc

Sold / distributed

Worldwide distribution. US nationwide, Mexico, and Korea.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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