Stryker Recalls Hoffmann II Carbon Connecting Rods Over Cracking Risk

Health Canada has issued a Type II recall for the Hoffmann® II Carbon Connecting Rod manufactured by Stryker GmbH, following confirmed reports that the medical device components may crack after routine cleaning and sterilization. The recall, identified under reference number RA-82242, affects all lots across seven catalogue numbers and was initiated on June 11, 2026. This recall is directed at healthcare professionals and medical facilities using this orthopaedic external fixation device.

What Products Are Being Recalled?

The recalled product is the Hoffmann® II Carbon Connecting Rod, an orthopaedic medical device used in external fixation systems. The recall covers all lots of the following catalogue numbers:

• Model 50796060
• Model 50796090
• Model 50796150
• Model 50796050
• Model 50796040
• Model 50796120
• Model 50796030

All lot numbers across each of these catalogue entries are included in the scope of this recall. The product is manufactured by Stryker GmbH, headquartered at Bohnackerweg 1, Selzach, Solothurn, Switzerland.

Why Was This Recall Issued?

Following product complaints submitted by healthcare users, Stryker GmbH investigated and confirmed that the Hoffmann® II Carbon Connecting Rods may develop cracks after undergoing cleaning and sterilization processes. This is classified as a performance issue under Health Canada’s medical device recall framework. The recall has been assigned a Type II classification, which indicates that the product may cause temporary adverse health consequences, or that the probability of serious adverse health consequences is remote but cannot be entirely ruled out.

The cracking behaviour, triggered by standard reprocessing procedures required in clinical settings, undermines the structural integrity of the connecting rod — a critical component in orthopaedic external fixation systems used to stabilize fractured bones during recovery.

Who Is Affected?

This recall is specifically directed at the healthcare audience, including hospitals, surgical centres, orthopaedic clinics, and any other medical facilities that stock or use the Hoffmann® II external fixation system. Patients who have undergone or are scheduled for procedures involving this device may also be indirectly affected. Healthcare professionals are urged to check their inventory immediately for any of the affected catalogue numbers.

The Hoffmann® II system is a widely used external fixator in orthopaedic trauma surgery. Its connecting rods play a structural role in maintaining bone alignment, meaning any compromise in rod integrity could impact patient outcomes during treatment.

What Should You Do?

• Immediately review your facility’s inventory for any Hoffmann® II Carbon Connecting Rods matching the catalogue numbers listed above.
• Quarantine and do not use any affected product until further guidance is received from Stryker GmbH.
• Contact the manufacturer, Stryker GmbH, directly for additional information and instructions on product return or replacement.
• Report any adverse events or device malfunctions related to this product to Health Canada through the established medical device reporting channels.
• Healthcare institutions should also notify their procurement and biomedical engineering teams to ensure no affected units remain in active rotation.

Official Statement

Health Canada has published this recall alert under its Recalls and Safety Alerts database. According to the official notice, Stryker has confirmed that cracking of the Hoffmann® II Carbon Connecting Rods may occur following cleaning and sterilization, and advises that healthcare professionals contact the manufacturer if additional information is required. The recall was originally published on June 23, 2026, and carries the identification number RA-82242. Health Canada continues to monitor the situation and encourages all affected parties to take immediate corrective action.