Depuy Orthopaedics Inc.: Medical Device Recall in 2016 - (Recall #: Z-0650-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 25, 2016

Date Posted: November 30, 2016

Recall Number: Z-0650-2017

Event ID: 75540

Reason for Recall:

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.

Status: Terminated

Product Quantity: 137

Code Information:

Product Codes: 201001210, ACTIS FLEX REAMER SZ 0/1, GTIN: 10603295434818; 201001220, ACTIS FLEX REAMER SZ 2/3, GTIN: 10603295434870; 201001230, ACTIS FLEX REAMER SZ 4/5, GTIN: 10603295434849; 201001240, ACTIS FLEX REAMER SZ 6/7, GTIN: 10603295434856; 201001250, ACTIS FLEX REAMER SZ 8/9, GTIN: 10603295434863; 201001260, ACTIS FLEX REAMER SZ 10/11, GTIN: 10603295434825; 201001270, ACTIS FLEX REAMER SZ 12, GTIN: 10603295434832

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated