FDA (Devices) recall action 85681
The FDA (Devices) publishes a recall like this one as 15 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 15 pages.
Seal integrity of the blister pack may be compromised and sterility cannot be assured
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 GmbH is recalling specific lots of locking screws because blister pack seals may be compromised, potentially affecting sterility.
Stryker GmbH is recalling specific lots of End Cap T2 Tibia implants because the blister pack seal may be compromised, meaning sterility cannot be assured.
Stryker GmbH is recalling specific lots of Locking Screws because the blister pack seal may be compromised, meaning sterility cannot be assured.
Stryker GmbH is recalling specific T2 Humerus End Cap implants because the blister pack seal may be compromised, meaning sterility cannot be assured.
Stryker GmbH is recalling specific locking screws because the blister pack seal may be compromised, meaning sterility cannot be assured.
Stryker is recalling specific lots of Locking Screws because the blister pack seal may be compromised, meaning sterility cannot be assured.
Stryker GmbH is recalling specific Advanced T2 Tibia Compression Screws because the blister pack seal integrity may be compromised, meaning sterility cannot be assured.
Stryker is recalling specific locking screws because the packaging seal may be compromised, meaning sterility cannot be assured.
Stryker is recalling specific lots of locking screws because the blister pack seal may be compromised, meaning sterility cannot be assured.
Stryker is recalling specific Humerus End Cap implants because the blister pack seal may be compromised, meaning sterility cannot be assured.
Stryker GmbH is recalling specific lots of Locking Screws because the blister pack seal may be compromised, meaning sterility cannot be assured.
Stryker GmbH is recalling specific lots of locking screws because the blister pack seal may be compromised, meaning sterility cannot be assured.
Stryker GmbH is recalling specific Gamma3 End Caps because the blister pack seal may be compromised, meaning sterility cannot be assured.
Stryker is recalling specific locking screws because the packaging seal may be compromised, meaning sterility cannot be assured.
Stryker GmbH is recalling specific End Cap implants because the blister pack seal may be compromised, meaning sterility cannot be assured.