DePuy ACTIS Flex Reamers Recalled Due to Breakage Risk
DePuy Orthopaedics is voluntarily recalling ACTIS Flex Reamers because the instruments may break and leave pieces in patients.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
DePuy Orthopaedics, Inc. is issuing a voluntary recall for all lots of the ACTIS Flex Reamers. The recall is being conducted because the instruments have been found to break, which poses a risk of leaving pieces inside the patient.
The affected products are ACTIS Flex Reamers in sizes 0/1, 2/3, 4/5, 6/7, 8/9, 10/11, and 12. These instruments are sold non-sterile and are packed within a rigid tube with foam protectors, a label, and instructions for use. A total of 137 units are subject to this recall.
The products were distributed in the United States to the states of California, Kentucky, Louisiana, Maryland, Maine, North Carolina, New Hampshire, New York, Texas, Virginia, and Washington. They were also distributed to Austria, Ireland, and Japan, as well as to VA/DOD facilities. Users of these medical devices should contact DePuy Orthopaedics for further instructions on how to proceed.
The recalled product
- Product
- 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
- Manufacturer
- Depuy Orthopaedics Inc.
- Hazard
- Affected units
- 137
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
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