FDA (Devices) recall action 94409
The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.
Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
The agency’s own wording, quoted from the enforcement report.
Exactech is recalling OPTETRAK One Peg Patella knee implants due to vacuum bags packaged below specification. The recall affects units with multiple lot numbers distributed worldwide.
Exactech is recalling OPTETRAK Advanced Patella knee implant components packaged in vacuum bags that did not meet manufacturing specifications. Improper packaging could compromise product sterility.
Exactech is recalling OPTETRAK Inset Patella knee implants packaged in out-of-specification vacuum bags that may compromise product integrity during storage or sterilization.
Exactech is recalling OPTETRAK Three Peg Patella knee components packaged in out-of-specification vacuum bags. The affected products were distributed worldwide.