Class 2 Device Recall

• Date Initiated by Firm: July 07, 2004
• Date Posted: October 08, 2004
• Recall Status: Terminated on October 07, 2004
• Recall Number: Z-0013-05
• Recall Event ID: 29513
• 510(K)Number: K990291
• Product Classification: Pin, Fixation, Smooth - Product Code HTY
• Product: Lactosorb pin, 2.0 x 20 mm, sterile; ref. 948205.
• Code Information: Lot 439010 Exp. 2006-11.
• Recalling Firm/ Manufacturer: Biomet, Inc.; 56 E Bell Dr; Warsaw IN 46582-6989
• For Additional Information Contact: Beth Albert; 800-348-9500 Ext. 1251
• Manufacturer Reason for Recall: Mislabeled as to size; 1.55 mm pins are labeled as 2mm.
• FDA Determined Cause: Other
• Action: Consignees were notified by recall letter dated July 7, 2004 and sent via fax.
• Quantity in Commerce: 37
• Distribution: Colorado, Mississippi, Missouri, Montana, New York, Ohio, Pennsylvania, Texas and Wisconsin.
• 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 = HTY