FDA (Devices) recall action 80371
The FDA (Devices) publishes a recall like this one as 18 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 18 pages.
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Stryker is recalling 22,831 AXS PP cranium plates because the sterile packaging may become compromised after three years.
Stryker is recalling Quikflap burr hole covers because the sterile packaging may become compromised after three years.
Stryker is recalling QUIKFLAP burr hole covers because the sterile packaging may become compromised after three years.
Stryker is recalling QUIKFLAP cranial plates because the sterile packaging may become compromised after three years, potentially affecting sterility.
Stryker is recalling QUIKFLAP burr hole covers because the sterile packaging may become compromised after three years.
Stryker is recalling AXS PP burr hole covers because the sterile packaging may become compromised after three years.
Stryker Leibinger is recalling QUIKFLAP cranium plates because the sterile packaging may become compromised after three years, potentially affecting sterility.
Stryker is recalling QUIKFLAP cranium plates because the sterile packaging may become compromised after three years, potentially affecting sterility.
Stryker is recalling QUIKFLAP burr hole covers because the sterile packaging may become compromised after three years.
Stryker is recalling AXS PP Burr Hole Covers because the sterile packaging may become compromised after three years, potentially affecting sterility.
Stryker is recalling QUIKFLAP cranium plates because the sterile packaging may become compromised after three years.
Stryker is recalling 22,831 AXS PP cranium plates because the sterile packaging may become compromised after three years.
Stryker is recalling QUIKFLAP burr hole covers because the sterile packaging may become compromised after three years.
Stryker is recalling QuickFlap Sterile Procedure Packs because the sterile barrier may become compromised after three years.
Stryker is recalling QUIKFLAP burr hole covers because the sterile packaging may become compromised after three years, potentially affecting sterility.
Stryker is recalling AXS PP burr hole covers because the sterile packaging may become compromised after three years, potentially affecting sterility.
Stryker is recalling QuickFlap Sterile Procedure Packs because the sterile barrier may become compromised after three years.
Stryker is recalling 22,831 AXS PP cranium plates because the sterile packaging may become compromised after three years.