Class 2 Device Recall Stryker Hoffmann II Connecting Rod Micro 3 x 120mm

• Date Initiated by Firm: July 01, 2026
• Date Posted: July 29, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2832-2026
• Recall Event ID: 99246
• 510(K)Number: K033476
• Product Classification: Appliance, fixation, nail/blade/plate combination, multiple component - Product Code KTT
• Product: Stryker Hoffmann II Connecting Rod Micro 3 x 120mm. Catalog Number: 50796120.
• Code Information: Catalog Number: 50796120. GTIN: 04546540389947. All lot numbers.
• FEI Number: 3002807830
• Recalling Firm/ Manufacturer: Stryker GmbH; Bohnackerweg 1; Selzach Switzerland
• For Additional Information Contact: Dannielle Stap; 269-5995110
• Manufacturer Reason for Recall: Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
• FDA Determined Cause: Device Design
• Action: Firm began notifying consignees on July 1, 2026. Customers were instructed to immediately check their internal inventory to locate affected product. Customers were informed that until further notice, the subject devices are limited to single use only. Following first use, discard the devices in accordance with the facility's established procedures. Users should conduct visual inspection of product prior to each use. If cracking is found to be present, the customer should quarantine non-confirming parts and report the issue to Stryker's Trauma & Extremities division. Rods with cracks should be returned as part of the complaint process.
• Quantity in Commerce: 5,439 units
• Distribution: Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, ID, IL, KS, LA, MA, MD, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NY, OH, PA, RI, SC, TN, TX, VA, WI, WV and the countries of Australia, Austria, Belgium, Canada, Chile, Denmark, France, Germany, Greece, Ireland, Israel, Italy, Japan, Kuwait, Netherlands, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, UK.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = KTT