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
Check against the official notice below — it lists the full affected range.
DePuy Orthopaedics, Inc. is voluntarily recalling all lots of ACTIS Flex Reamers in sizes 0/1, 2/3, 4/5, 6/7, 8/9, 10/11, and 12. These non-sterile surgical instruments, which are packaged in rigid tubes with foam protectors, have been found to break during use, potentially leaving fragments inside patients. A total of 137 units were distributed across the United States (California, Kentucky, Louisiana, Maryland, Maine, North Carolina, New Hampshire, New York, Texas, Virginia, and Washington) and internationally to Austria, Ireland, and Japan.
The recall affects multiple product codes and lot numbers specific to each reamer size. The source does not specify what an affected consumer should do in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: US Distribution to the states of: CA, KY, LA, MD, ME, NC, NH, NY, TX, VA, WA Foreign: Austria, Ireland, and Japan VA/DOD: Quantity: 137 Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.