Class 3 Device Recall Bone Screw

• Date Initiated by Firm: April 02, 2009
• Date Posted: September 22, 2009
• Recall Status: Terminated on September 23, 2009
• Recall Number: Z-2298-2009
• Recall Event ID: 51730
• 510(K)Number: K042237
• Product Classification: Bone fixation appliances - Product Code HSB
• Product: Bone Screw 4.5MM X 70MM Bone Screw Lock, Rx only Biomet, 100 Interpace Parkway, Parsippany, NJ 070454 The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws.
• Code Information: Item number 27870, lot numbers 741860, 744730
• Recalling Firm/ Manufacturer: EBI, L.P.; 100 Interpace Pkwy; Parsippany NJ 07054-1149
• For Additional Information Contact: William Hennig; 973-299-9300 Ext. 1557
• Manufacturer Reason for Recall: Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
• FDA Determined Cause: Nonconforming Material/Component
• Action: The firm sent Urgent Recall Notices to all direct accounts, hospital Risk Management and Physicians by first class mail. Letters are dated March 29, 2009, April 2, 2009 and April 16, 2009 respectively. The letter describes the problem and that that there is a possible risk of a device failure. An additional e-mail was sent on May 22, 2009 to 5 customers due to an expansion of the recall to include 4 additional items. On June 19, 2009, the firm again expanded the recall to include 2 additional products and notified customers. Questions should be directed to William Hennig, at 1.973.299.9300. ext. 1557.
• Quantity in Commerce: 29
• Distribution: Worldwide - US -NY, NJ, MI, MD, FL, GA, PR, MN, SD, OK, TX,, LA, CA, PA, OH, NV, HI, ME, NC, KS, UT, CO, TN, WV, VA, and WA. Foreign: Brazil, Colombia, Denmark, Germany, Finland, Greece, Italy, Japan, The Netherlands, Switzerland, Sweden, Portugal, Spain, United Kingdom, Saudi Arabia, and Trinidad.
• 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