FDA (Devices) recall action 99246
The FDA (Devices) publishes a recall like this one as 7 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 7 pages.
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
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 Hoffmann II Carbon Connecting Rods (catalog 50796040) because they may crack after cleaning and sterilization.
Stryker is recalling Hoffmann II Carbon Connecting Rods (catalog 50796120) because the rods may crack after cleaning and sterilization. The recall covers 5,439 units distributed worldwide.
Stryker GmbH is recalling Hoffmann II Carbon Connecting Rods (catalog 50796090) because they may crack after cleaning and sterilization. The FDA classified this as a Class II recall.
Stryker GmbH is recalling Hoffmann II Carbon Connecting Rods (catalog 50796060) because they may crack after cleaning and sterilization. The recall covers all lots and about 9,658 units distributed worldwide.
Stryker is recalling Hoffmann II Connecting Rod Micro 3 x 30mm (catalog 50796030) because the rods may crack after cleaning and sterilization. FDA has classified this as Class II.
Stryker GmbH is recalling Stryker Hoffmann II Connecting Rod Micro 3 x 50mm due to a potential risk of the rods cracking after cleaning and sterilization.
Stryker GmbH is recalling Stryker Hoffmann II Connecting Rod Micro 3 x 150mm due to the potential for the rods to crack following cleaning and sterilization processes.