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Class 2 Device Recall Orthopedic Manual surgical instrument |
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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
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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.
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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
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For Additional Information Contact |
Audrey Daenzer 574-372-1570
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Manufacturer Reason for Recall |
Investigation determined that units supplied were missing the 4x21 degree helix angle.
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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
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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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