Stryker Sustainability Solutions — Class II: REF:2B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEE
Stryker Sustainability Solutions has initiated a Class II recall for Ethicon Endo-Surgery Xcel Bladeless Trocars with Optiview Technology (5mm x 75mm). The recall was prompted by reports that the reusable access port system may crack or separate during clinical use.
This recall affects Stryker Sustainability Solutions, healthcare facilities utilizing reprocessed Ethicon bladeless trocars, and surgical staff involved in laparoscopic procedures.
Structural failure of an access port during surgery presents risks of procedural delay or potential patient injury if components detach. For regulatory professionals, this underscores the mechanical integrity challenges inherent in reprocessed Class II devices, where material stress from multiple sterilization cycles or uses may lead to component separation.
Facilities should immediately identify and quarantine affected lots of REF:2B5ST. Quality units should review internal complaint data for similar structural failures in reprocessed trocars and assess if current inspection protocols are sufficient to detect material fatigue or stress cracking.
Class II. Reason: Reusable access port system may crack or seperate during use.. Product: REF:2B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 75MM. Firm: Stryker Sustainability Solutions (Tempe AZ United States). Status: Ongoing.
Open in openFDA / FDA.gov