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U.S. Department of Health and Human Services

Class 2 Device Recall Integra Ruggles Surgical Instrument ACF Distraction Screws

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  Class 2 Device Recall Integra Ruggles Surgical Instrument ACF Distraction Screws see related information
Date Initiated by Firm October 22, 2008
Date Posted January 23, 2009
Recall Status1 Terminated 3 on July 15, 2009
Recall Number Z-0854-2009
Recall Event ID 50112
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product Integra Ruggles Surgical Instrument ACF Distraction Screws
Sterile, Rx only
Catalog number R6357A (12 mm), Catalog number R6397A (16 mm),
Integra LifeSciences Corp., 311 Enterprise Drive, Plainsboro, NJ 08536
Code Information lot code 326081; and lot code 327081.
Recalling Firm/
Integra LifeSciences Corp.
311 Enterprise Dr
Plainsboro NJ 08536-3344
For Additional Information Contact Jon Caparotta
Manufacturer Reason
for Recall
A packaging error had occurred where 16 mm screws were packaged and labeled as 12 mm screws and vice versa.
FDA Determined
Cause 2
Action Urgent: Product Recall Notification letters were sent via Fed Ex on October 22, 2008. The letter asked customers to quarantine any of the affected stock on hand and contact their local Integra Sales Representative for further assistance and for arrangement of product returns. Customers were to fill out the attached "Recall Acknowledgement and Return Form" indicating whether or not they possess any of the product identified in the letter. Additional questions can be directed to Christin Roach at 609-936-5413. A Urgent: Product Recall Second Notification dated 1/5/2009 was sent to customers providing them with additional information on the packaging error and included immediate and/or product used during surgery. This notification also requested that all surgeons be notified who were or may have been provided with any of the screws affected by this recall.
Quantity in Commerce 351 units
Distribution Nationwide Distribution
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.