Class 2 Device Recall BIOLOX

• Date Initiated by Firm: June 30, 2017
• Create Date: March 14, 2018
• Recall Status: Terminated on April 13, 2018
• Recall Number: Z-0992-2018
• Recall Event ID: 79242
• 510(K)Number: K131684
• Product Classification: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
• Product: DELTA CER FEM HD 32/0MM T1; ; Product Usage:; For use in hip arthroplasty
• Code Information: part number: 650-1162 lot number: 2016030466
• Recalling Firm/ Manufacturer: Zimmer Biomet, Inc.; 56 E Bell Dr; Warsaw IN 46582-6989
• Manufacturer Reason for Recall: Product may contain the presence of melted sterile packaging upon opening.
• FDA Determined Cause: Packaging process control
• Action: On June 2, 2017 an URGENT Medical Recall Letter was issued to customers regarding affected product(s). The letter requests customers to review the content and notify affected personnel of the recall. Assist the sales representative in quarantining affected product, which will be removed and returned to recalling firm and then replaced. All customers who may have received product from distributors are to be notified. Questions or concerns can be directed to 1-574-372-4847.
• Quantity in Commerce: 30
• Distribution: US in the state of Texas
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LZO and Original Applicant = BIOMET, INC.