Class 2 Device Recall Zimmer M/DN Intramedullary Fixation System

• Date Initiated by Firm: May 04, 2016
• Date Posted: May 16, 2016
• Recall Status: Terminated on July 05, 2017
• Recall Number: Z-1678-2016
• Recall Event ID: 73981
• 510(K)Number: K142281
• Product Classification: Rod, fixation, intramedullary and accessories - Product Code HSB
• Product: M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 45 mm Length 00225304542 M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 70 mm Length 00225307042
• Code Information: LOTS: 63295051 63293672
• Recalling Firm/ Manufacturer: Zimmer Manufacturing B.V.; Turpeaux Industrial Park Rd 1 km 123.4; Mercedita PR 00715
• Manufacturer Reason for Recall: A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
• FDA Determined Cause: Packaging change control
• Action: All distributors will be notified via electronic mail. Distributors with affected lots will also be notified via courier. Hospitals risk managers and surgeons will be notified via recall notification letter, dated May 4, 2016.
• Quantity in Commerce: 219
• Distribution: Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
• 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 = HSB