FDA-Device2016-11-30Class II
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
Depuy Orthopaedics Inc.
Hazard
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.
Sold states
US Distribution to the states of: CA, KY, LA, MD, ME, NC, NH, NY, TX, VA, WA Foreign: Austria, Ireland, and Japan VA/DOD:
Affected count
137
Manufactured in
700 Orthopaedic Dr, N/A, Warsaw, IN, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0650-2017Don't want to check this manually?
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