Stryker GmbH — Class II: Stryker Hoffmann II Connecting Rod Micro 3 x 90mm. Catalog Number: 50796090.
Stryker GmbH has initiated a Class II recall for the Stryker Hoffmann II Connecting Rod Micro 3 x 90mm (Catalog Number: 50796090) due to reports of potential cracking following cleaning and sterilization processes. The recall is currently classified as ongoing by the FDA.
This affects Stryker GmbH, orthopedic surgical facilities using the Hoffmann II external fixation system, and hospital sterile processing departments responsible for device reprocessing.
Structural failure of carbon connecting rods post-sterilization suggests a potential vulnerability in the material integrity or a compatibility issue with standard reprocessing cycles. This situation may necessitate a review of cleaning agent concentrations or sterilization parameters to prevent intraoperative or post-operative component failure.
QA and clinical teams should verify inventory for the specified catalog number and assess current cleaning and sterilization protocols against manufacturer instructions for use. Regulatory teams should monitor for updated labeling or handling instructions regarding rod integrity post-processing.
Class II. Reason: Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.. Product: Stryker Hoffmann II Connecting Rod Micro 3 x 90mm. Catalog Number: 50796090.. Firm: Stryker GmbH (Selzach N/A Switzerland). Status: Ongoing.
Open in openFDA / FDA.gov