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U.S. Department of Health and Human Services

Class 2 Device Recall Distal Femoral Jig

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  Class 2 Device Recall Distal Femoral Jig see related information
Date Initiated by Firm October 15, 2014
Date Posted November 10, 2014
Recall Status1 Terminated 3 on November 19, 2015
Recall Number Z-0199-2015
Recall Event ID 69271
Product Classification Orthopedic manual surgical instrument - Product Code LXH
Product ATTUNE Intuition Distal Femoral Jig; sold non-sterile; product is wrapped in bubble wrap and then sealed inside a polyethylene bag
Code Information Catalog NOs. 2544-00-521 and 2544-00-520; All lots are affected for the Device Correction.   Lot numbers below should be inspected and swapped out if the bushing is incorrectly assembled: Part No. DePuy Synthes Lot No: MFG Lot No: 254400520 ABC22844 C22844  ABC22845 C22845  ABC34279 C34279  ABC34280 C34280  ABC4107 C4107  ABC4108 C4108  ABC4112 C4112  ABC4113 C4113  ABC50741 C50471 254400521 ABB13662 B13662  ABB19116 B19116  ABB19117 B19117  ABB19118 B19118  ABB35392 B35392  ABB35393 B35393  ABB39835 B39835  ABB41384 B41384  ABB46872 B46872  ABB49200 B49200  ABB50724 B50724  ABB55749 B55749  ABB63598 B63598  ABB66346 B66346  ABB72107 B72107  ABB77183 B77183  ABB79390 B79390  ABB79391 B79391  ABB80712 N80712  ABC17165 C17165  ABC5023 C5023
Recalling Firm/
Manufacturer
DePuy Orthopaedics, Inc.
700 Orthopaedic Dr
Warsaw IN 46582-3994
For Additional Information Contact Kimberly C. Earle
574-267-8143
Manufacturer Reason
for Recall
Issuing a device correction because if the pin bushing is over loaded or inverted, there is the potential for partial or full displacement and fracture of the plastic around the pin bushing.
FDA Determined
Cause 2
Process control
Action DePuy sent an "URGENT DEVICE CORRECTION" notifications dated October 15, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions, please call 574-371-4917.
Quantity in Commerce 3,082
Distribution Worldwide Distribution - USA (nationwide) except AK, including Puerto Rico and the countries of Canada, Australia, Austria, Belgium, China, France, Germany, India, Ireland, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Singapore, South Africa, South Korea, Spain, Switzerland, Thailand, UAE, United Kingdom and Chile.
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.
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