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U.S. Department of Health and Human Services

Class 2 Device Recall Orthopedic Manual surgical instrument

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  Class 2 Device Recall Orthopedic Manual surgical instrument see related information
Date Initiated by Firm September 17, 2014
Date Posted October 06, 2014
Recall Status1 Terminated 3 on July 14, 2015
Recall Number Z-0021-2015
Recall Event ID 69280
Product Classification Reamer - Product Code HTO
Product Compress Face Reamer

Product Usage:
Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.
Code Information Catalog numbers: 32-481000  Lot Numbers: 615860, 765230  Catalog Number: 32-481001 Lot Number Identification: 121450, 392410, 765250, 974290
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46581
For Additional Information Contact Audrey Daenzer
574-372-1570
Manufacturer Reason
for Recall		 Investigation determined that units supplied were missing the 4x21 degree helix angle.
FDA Determined
Cause 2		 Process control
Action On September 17, 2014, "URGENT MEDICAL DEVICE RECALL NOTICE" was sent to the consignee Biomet Global Supply Chain Center (GSCC) by email and FedEx. GSCC notified all of the customers within Europe, the Middle East, and Asia that received the affected product. The recall notification included a description of the reason for recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions, call (574) 372-1570.
Quantity in Commerce 4
Distribution International Distribution in the countries of Netherlands, Europe, the Middle East, and Asia.
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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