Class 2 Device Recall Trabecular Metal acetabular Augments

• Date Initiated by Firm: April 06, 2010
• Date Posted: August 12, 2010
• Recall Status: Terminated on October 21, 2011
• Recall Number: Z-2217-2010
• Recall Event ID: 55364
• 510(K)Number: K061067
• Product Classification: prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
• Product: Trabecular Metal acetabular revision system column buttress right posterior/left anterior, 00-4894-400-00, sterile, Zimmer Inc., Parsippany, NJ.
• Code Information: 60492197, 60704071, 60667465, 60728122, 60770944, 60796679, 60862513, 61081548, 61143008, and 61324533.
• Recalling Firm/ Manufacturer: Zimmer Inc.; 345 E Main St; Warsaw IN 46580-2746
• For Additional Information Contact: 574-267-6131
• Manufacturer Reason for Recall: The firm has determined that some of the packages could develop a breach of the seal in the sterile barrier pouches.
• FDA Determined Cause: Packaging
• Action: The firm sent an "Urgent Device Removal" letter dated 4/6/2010. The consignees were instructed to inventory the products on hand and return the recalled product to the manufacturer. More information is available at 1-800-613-6131.
• Quantity in Commerce: 1,972 all products
• Distribution: US, Germany, Brazil, Singapore, Canada, Australia, England, India, and Switzerland.
• 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 = LPH and Original Applicant = ZIMMER TRABECULAR