Stryker GmbH — Class II: Stryker Hoffmann II Connecting Rod Micro 3 x 40mm. Catalog Number: 50796040.
Stryker GmbH has initiated a Class II recall for the Hoffmann II Connecting Rod Micro (3 x 40mm) due to potential cracking of the carbon connecting rods following cleaning and sterilization processes.
This recall affects Stryker GmbH, orthopedic surgical centers utilizing the Hoffmann II system, and professionals responsible for device reprocessing and sterile services.
The structural integrity of carbon-based external fixation components is critical for patient stabilization. Potential cracking post-sterilization suggests a possible vulnerability in the device material or a conflict with standard reprocessing instructions, which could lead to mechanical failure during clinical use.
Quality and sterilization teams should verify inventory for the affected catalog number and review internal cleaning/sterilization protocols for potential material degradation signals. Regulatory teams should monitor the status of this ongoing recall to ensure proper reporting of any related field actions.
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 40mm. Catalog Number: 50796040.. Firm: Stryker GmbH (Selzach N/A Switzerland). Status: Ongoing.
Open in openFDA / FDA.gov