Reported Nov 30, 2016 · Terminated
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…
Depuy Orthopaedics Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Depuy Orthopaedics Inc. · 700 Orthopaedic Dr · Warsaw, IN · 46582-3994
Is this the product you have?
ACTIS Flex Reamers SZ 0/12/34/56/78/910/1112Product is sold non-sterilethese instruments are packed non-sterilewithin a rigid tube with foam protectorswith label and IFU
- Lot codes and dates
- Product Codes
201001210ACTIS FLEX REAMER SZ 0/1
- GTIN
10603295434818201001220ACTIS FLEX REAMER SZ 2/3
- GTIN
10603295434870201001230ACTIS FLEX REAMER SZ 4/5
- GTIN
10603295434849201001240ACTIS FLEX REAMER SZ 6/7
- GTIN
10603295434856201001250ACTIS FLEX REAMER SZ 8/9
- GTIN
10603295434863201001260ACTIS FLEX REAMER SZ 10/11
- GTIN
10603295434825201001270ACTIS FLEX REAMER SZ 12
- GTIN10603295434832
- Product Codes
- Amount recalled
- 137
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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