FDA (Devices) recall action 66499
The FDA (Devices) publishes a recall like this one as 8 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 8 pages.
Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. This testing determined that a packaging tray configuration which consists of an inner and outer sterile tray, resulted in failure
The agency’s own wording, quoted from the enforcement report.
Zimmer, Inc. is recalling NGK Stem Extenders because testing revealed that a specific packaging tray configuration failed to maintain sterile barrier integrity.
Zimmer, Inc. is recalling 42,065 Tibia Nails because testing revealed that a specific packaging tray configuration failed to maintain sterile barrier integrity.
Zimmer, Inc. is recalling ITST Threaded Guide Pins because testing found that a specific packaging tray configuration failed to maintain sterile barrier integrity.
Zimmer, Inc. is recalling 42,065 distal lateral femoral locking plates because testing revealed that a specific packaging tray configuration failed to maintain sterile barrier integrity.
Zimmer, Inc. is recalling 42,065 units of Distal Lateral Femoral Locking Plates because packaging testing revealed failures in sterile barrier integrity.
Zimmer, Inc. is recalling 42,065 femoral condylar buttress plates because packaging testing revealed failures in sterile barrier integrity.
Zimmer, Inc. is recalling 42,065 units of Tibio Fem/Fem Nail because testing revealed a packaging tray configuration that failed sterile barrier integrity requirements.
Zimmer, Inc. is recalling specific femoral condylar buttress plates because testing revealed a packaging configuration that failed sterile barrier integrity requirements.