ACTIS Flex Reamers SZ 0/1 recalled over sterility concerns

Recall date

October 25, 2016

Source

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

Official notice title

Depuy Orthopaedics Inc. recalls ACTIS Flex Reamers SZ 0/1; 2/3; 4/5; 6/7; 8/9; 10/11; 12, Product is sold non-sterile, these instruments are packed non…

Recall number

Z-0650-2017

FDA classification

Class II

Brand / firm

Depuy Orthopaedics Inc.

Sold / distributed

US Distribution to the states of: CA, KY, LA, MD, ME, NC, NH, NY, TX, VA, WA Foreign: Austria, Ireland, and Japan VA/DOD:

Why it was recalled

DePuy Orthopaedics, Inc. is issuing a voluntary recall for all lots of the ACTIS Flex Reamers due to the instruments breaking and potentially leaving pieces in the patient.

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

What was recalled

ACTIS Flex Reamers SZ 0/1; 2/3; 4/5; 6/7; 8/9; 10/11; 12, Product is sold non-sterile, these instruments are packed non-sterile, within a rigid tube with foam protectors, with label and IFU