Class 2 Device Recall Orthopedic Manual Surgical Instrument

• Date Initiated by Firm: February 16, 2016
• Date Posted: February 25, 2016
• Recall Status: Terminated on February 14, 2017
• Recall Number: Z-0885-2016
• Recall Event ID: 73258
• Product Classification: Orthopedic manual surgical instrument - Product Code LXH
• Product: HipLOC CHS Plate/Lag Screw Introducer
• Code Information: Catalog Number: 35-000263; and Lot Number Identification: 1807188, 1807189, 1943563, and 2577847.
• Recalling Firm/ Manufacturer: Biomet, Inc.; 56 E Bell Dr; Warsaw IN 46582-6989
• For Additional Information Contact: Amanda Zajicek; 574-372-6782
• Manufacturer Reason for Recall: A complaint was received where the Hiploc Plate/Lag Screw Introducer was undersized and would not accept the introducor coupling screw. It appears now that not all parts manufactured to Rev A drawing were reworked.
• FDA Determined Cause: Process change control
• Action: Biomet sent an " URGENT MEDICAL DEVICE RECALL NOTICE" dated February 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The following actions are REQUIRED: Immediately locate and remove the identified device(s) listed below from circulation. Remove the affected product from circulation. Review this notification and ensure that all affected personnel are aware of its contents. Carefully follow the instructions on the enclosed Response Form . Email a copy of the response form to CPWARFieldAction@zimmerbiomet.com prior to return of product. You do not need to complete the Biomet UK response form. Use priority carrier for your shipment. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA: "Online: www.fda.gov/Safety/MedWatch/HowToReport/default.htm (form available to fax or mail), or "Call (800)FDA-1088 Thank you in advance for your assistance and prompt attention. On behalf of Zimmer Biomet, I apologize for any inconvenience this may cause. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.
• Quantity in Commerce: 23 units
• Distribution: US Distribution to the states of : MO, UT, AZ, IL, PA, KY, MI, NC, NJ, MN and GA., and Internationally to The Netherlands.
• 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.