AllClear
PricingSign in
FDAOctober 25, 2016device

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 recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

depuy orthopaedicsdepuy

UPCs

10603295434818106032954348701060329543484910603295434856106032954348631060329543482510603295434832

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

Own something like this?

AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.

Start free — 200 items, no card →