Class 2 Device Recall NovoHip Total Hip System

• Date Initiated by Firm: September 19, 2024
• Date Posted: November 18, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0483-2025
• Recall Event ID: 95598
• 510(K)Number: K132158
• Product Classification: Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
• Product: NovoHip Biolox Ball Head 32mmL Ref: 1345-2803 NovoHip Total Hip System - NovoHip Total Hip System is a non-cemented hip prosthesis that consists of a 4-part total hip replacement system including femoral stem, femoral head, acetabular poly liner, and acetabular metal (or shell) components.
• Code Information: UDI-DI 00811382037849; Lot Number CER0023
• Recalling Firm/ Manufacturer: Novosource, LLC; 2000 Hampton Ctr Ste C; Morgantown WV 26505-1704
• For Additional Information Contact: Melinda Larkin; 724-998-9232
• Manufacturer Reason for Recall: Mislabeled: Packaged in a box labeled as 32 long but containing a 28 long head by physical marking, may result in joint instability if implanted
• FDA Determined Cause: Mixed-up of materials/components
• Action: NovoSource LLC issued Urgent Medical Device Recall letter on 9/13/24 via email. Letter states reason for recall, health risk and action to take: "Immediate Action Discontinue Use: All customers and healthcare providers should immediately discontinue the use of the affected product batches. Surgical teams should not use any Biolox Delta Ceramic Head implants from the mislabeling-affected batches in any hip replacement surgeries. "Return or Segregation of Affected Product: Affected implants should be removed from active inventory and returned to NovoSource. Providers should follow instructions for proper packaging and shipping of the returned products. Any products not yet returned should be clearly labeled as "Do Not Use" and quarantined from inventory until shipment back to NovoSource. Instructions on how to return products will be provided, including the appropriate return address and contact person for support during this process. " For Unused Products: Customers should ensure that all unused products from the affected batches are returned to NovoSource. This will prevent any risk of improper head-liner fitting due to the mislabeling. "For Implanted Products: If the mislabeled product has already been implanted, surgeons should be prepared to monitor the patient for symptoms consistent with the mismatch. A mismatch of a 32 long head implanted into a 28 liner would likely have instability issues. A 28 long head implanted into a 32 liner will likely act very similarly in stability and alignment, while wear should not be catastrophic. The surgeon should monitor the patient to determine if symptoms appear that would result in the need to revise. Actions to Be Taken Pending Corrective or Removal Action: "Stop Usage: Healthcare facilities should stop any further use of the affected product batches pending completion of the recall process. NovoSource will provide updates on the investigation and resolution. "Notification to Surgical Teams: IF IMPLANTED, it is essential
• Quantity in Commerce: 1 unit
• Distribution: Florida, West Virginia
• 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 = LPH