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Class 2 Device Recall Vanguard M Series Unicondylar Tibial Bearings |
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Date Initiated by Firm |
April 22, 2015 |
Date Posted |
June 15, 2015 |
Recall Status1 |
Terminated 3 on March 22, 2016 |
Recall Number |
Z-1798-2015 |
Recall Event ID |
71253 |
510(K)Number |
K042093
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Product Classification |
Prosthesis, knee, femorotibial, semi-constrained, cemented, metal/polymer - Product Code HRY
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Product |
Vanguard M Unicondylar Tibial Trial
For use during knee joint replacement. |
Code Information |
Part 32-423101 Lot 414930 Part 32-423102 Lot 116490 Part 32-423106 Lot 785220 Part 32-423107 Lot 873780 Part 32-423108 Lot 070420 and 785250 Part 32-423109 Lot 670630 Part 32-423115 Lot 672920 Part 32-423119 Lot 785290 Part 32-423116 Lot 073640 Part 32-423101 Lot 785170 Part 32-423102 Lot 785180 Part 32-423109 Lot 785260 Part 32-423124 Lot 024760 Part 32-423110 Lot 785270 |
Recalling Firm/ Manufacturer |
Biomet, Inc. 56 E Bell Dr Warsaw IN 46582-6989
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For Additional Information Contact |
Audrey Daenzer 574-372-1570
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Manufacturer Reason for Recall |
The Left and Right orientation of the trial was incorrectly etched on one side. When the instrument is rotated about the axis of the handle 180 degrees to view the other side, the etch on the handle now shows R on the same side as the keel marked LM and the L on the same side as the keel marked RM. This is incorrect. Please note that the keel is not etched on this side by design.
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FDA Determined Cause 2 |
Process control |
Action |
On 4/22/2015, URGENT MEDICAL DEVICE RECALL NOTICE notifications, dated April 22, 2015 were sent to the affected distributors with instructions for returning the affected product. 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. Customers are required to immediately locate and remove the affected product from circulation, follow the instructions on the "Response Form," and e-mail a copy of the completed form to the designated e-mail address prior to returning the product. Additionally, if the affected product has been further distributed, the necessary personnel must notified via the "Dear Risk/Recall Manager" notice. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m. |
Quantity in Commerce |
27 |
Distribution |
Worldwide Distribution -- US, including the state of IL, NJ, Canada, Netherlands, and Chile. |
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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510(K) Database |
510(K)s with Product Code = HRY and Original Applicant = BIOMET, INC.
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