Onkos Surgical, Inc. — Class II: Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M
Onkos Surgical, Inc. initiated a Class II recall for its My3D Personalized Pelvic Implant due to the inadvertent mix-up and distribution of personalized implants to incorrect customers.
This recall affects Onkos Surgical, Inc., orthopedic surgeons, and hospital facilities utilizing patient-specific pelvic implants, as well as QA and logistics personnel responsible for the distribution of personalized medical devices.
The distribution of a personalized implant to the wrong patient represents a significant failure in the labeling or fulfillment process. For custom or personalized devices, such errors can result in surgical delays or the potential for an incorrect device to be implanted if the mismatch is not identified at the point of care. This suggests a potential deficiency in the firm's identity verification or tracking procedures during the final stages of the supply chain.
QA and logistics teams should verify the robustness of final labeling and pick-and-pack protocols for patient-matched devices. Regulatory teams should evaluate if existing tracking systems are sufficient to prevent the cross-distribution of personalized implants during the distribution phase.
Class II. Reason: Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers.. Product: Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M. Firm: Onkos Surgical, Inc. (Parsippany NJ United States). Status: Ongoing.
Open in openFDA / FDA.gov