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U.S. Department of Health and Human Services

Class 2 Device Recall Vanguard Total Knee System

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  Class 2 Device Recall Vanguard Total Knee System see related information
Date Initiated by Firm January 04, 2017
Create Date January 28, 2017
Recall Status1 Open3, Classified
Recall Number Z-1115-2017
Recall Event ID 75973
510(K)Number K023546  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product Vanguard Total Knee System
Vanguard Open Box Femoral Components

Item Number: 183100
Description: VNGD PS OPEN INTL FEM RT 55
Item Number: 183102
Description: VNGD PS OPEN INTL FEM-RT 57.5
Item Number: 183104
Description: VNGD PS OPEN INTL FEM RT 60
Item Number: 183106
Description: VAN PS OPEN INTL FEM-RT 62.5
Item Number: 183108
Description: VAN PS OPEN INTL FEM-RT 65
Item Number: 183110
Description: VAN PS OPEN INTL FEM-RT 67.5
Item Number: 183112
Description: VAN PS OPEN INTL FEM-RT 70
Item Number: 183113
Description: VAN PS OPEN INTL FEM-RT 72.5
Item Number: 183120
Description: VAN PS OPEN INTL FEM-LT 55
Item Number: 183122
Description: VAN PS OPEN INTL FEM-LT 57.5
Item Number: 183124
Description: VAN PS OPEN INTL FEM-LT 60
Item Number: 183126
Description: VAN PS OPEN INTL FEM-LT 62.5
Item Number: 183128
Description: VAN PS OPEN INTL FEM-LT 65
Item Number: 183130
Description: VAN PS OPEN INTL FEM-LT 67.5
Item Number: 183132
Description: VAN PS OPEN INTL FEM-LT 70
Item Number: 183133
Description: VAN PS OPEN INTL FEM-LT 72.5
Code Information 58445, J3773121, J3783491, J3792579, J3801332, J3807732, J3814229, J3825037, J3842154, J3851814, J3799366, J3764285, J3773123, J3783492, J3792580, J3801333, J3807733, J3814230, J3825038, J3842155, J3851815, J3802724, J3764286, J3773124, J3783493, J3792581, J3801334, J3807734, J3814231, J3825039, J3842156, J3851816, J3827675, J3764289, J3773125, J3783494, J3792582, J3801335, J3807735, J3814232, J3825040, J3842157, J3851817, J3830005, J3764303, J3774972, J3785399, J3792583, J3801336, J3807736, J3814233, J3825412, J3842161, J3851818, J3830669, J3764304, J3774974, J3786172, J3795001, J3801337, J3807737, J3815903, J3825413, J3844465, J3854413, J3849179, J3764306, J3774975, J3786173, J3795004, J3801338, J3807738, J3815904, J3825414, J3844466, J3854414, J3849184, J3764307, J3774976, J3786174, J3795006, J3801339, J3807749, J3815905, J3825415, J3844467, J3854416, J3849186, J3764308, J3774977, J3786175, J3795008, J3802725, J3807750, J3816075, J3826890, J3844472, J3854417, J3854387, J3764312, J3774978, J3786179, J3795009, J3802726, J3807751, J3816076, J3826892, J3844473, J3854419, J3854418, J3764340, J3774979, J3786181, J3795010, J3802727, J3807752, J3816077, J3826893, J3844475, J3854421, J3854428, J3764341, J3774980, J3786183, J3795011, J3802728, J3807753, J3816078, J3826894, J3844476, J3854422, J3854429, J3764342, J3774981, J3786184, J3795012, J3802729, J3807754, J3816079, J3826895, J3844477, J3854423, J3854433, J3764343, J3774982, J3786186, J3795014, J3802730, J3807755, J3816080, J3827676, J3844478, J3854424, J3854438, J3764344, J3778368, J3786188, J3795016, J3802731, J3807756, J3818065, J3827677, J3844479, J3854430, J3854440, J3764345, J3778372, J3787568, J3795017, J3802732, J3807757, J3818066, J3830006, J3847267, J3854431, J3854479, J3764346, J3778374, J3787569, J3795018, J3802733, J3807758, J3818067, J3830007, J3847268, J3854432, J3854480, J3768957, J3778396, J3787570, J3795021, J3802734, J3808893, J3818068, J3830008, J3847269, J3854435, J3854484, J3768960, J3778397, J3787571, J3798275, J3802735, J3808894, J3818069, J3830668, J3847270, J3854436, J3854485, J3769007, J3778398, J3787573, J3798276, J3802736, J3808895, J3818070, J3830670, J3847271, J3854442, J3854487, J3769009, J3778399, J3789423, J3798433, J3802737, J3808896, J3818071, J3830671, J3847272, J3854477, J3857400, J3769010, J3778400, J3789424, J3798434, J3802738, J3808897, J3818072, J3830672, J3847273, J3854478, J3769329, J3778401, J3789425, J3799358, J3803266, J3808898, J3818073, J3830673, J3847274, J3854483, J3769330, J3778402, J3789426, J3799359, J3803267, J3808899, J3818074, J3833260, J3847275, J3854488, J3769332, J3778403, J3789427, J3799360, J3803268, J3808900, J3819270, J3833261, J3847276, J3854490, J3769333, J3778404, J3789428, J3799361, J3804239, J3810104, J3819271, J3833262, J3849174, J3854492, J3769340, J3778405, J3789429, J3799362, J3804240, J3810105, J3821137, J3834938, J3849175, J3854494, J3769341, J3779269, J3789430, J3799363, J3804241, J3810106, J3823531, J3834939, J3849176, J3857401, J3769343, J3779270, J3789432, J3799364, J3806985, J3810107, J3823532, J3834940, J3849178, J3857409, Item Number: 183128, Description: VAN PS OPEN INTL FEM-LT 65, Lot Numbers:, J3747489, J3762544, J3779260, J3786127, J3799052, J3803341, J3810080, J3825400, J3838221, J3847228, J3856903, J3750140, J3764297, J3781709, J3786129, J3799053, J3803342, J3810081, J3826874, J3838222, J3848977, J3753337, J3751054, J3764298, J3781711, J3786130, J3799054, J3803343, J3812140, J3826875, J3838223, J3848978, J3759821, J3753334, J3764299, J3781712, J3786131, J3799055, J3803344, J3812141, J3826876, J3838224, J3848979, J3767794, J3754909, J3764300, J3781714, J3789368, J3799056, J3803345, J3812142, J3826877, J3838232, J3848980, J3769322, J3759813, J3764301, J3781715, J3794829, J3799057, J3803346, J3812143, J3826878, J3838233, J3848994, J3786118, J3759817, J3767795, J3781716, J3797366, J3799058, J3807360, J3812144, J3826879, J3840014, J3848995, J3789366, J3759818, J3767796, J3781717, J3797367, J379906
Recalling Firm/
Manufacturer
Zimmer Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact Customer Service
574-371-3071
Manufacturer Reason
for Recall
packaging of some femoral components was incorrectly labeled as either smaller or larger and/or as the incorrect side (right/left). Risk delay in surgery.
FDA Determined
Cause 2
Process change control
Action On 1/4/2017 URGENT MEDICAL DEVICE RECALL REMOVAL- LOT SPECIFIC notifications were sent to the affected distributors and hospital Risk Managers via courier. 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. Distributor responsibilities include: 1. Review this notification and ensure affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Complete the Certification of Acknowledgement portion of Attachment 1  Inventory Return Certification Form a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com within three (3) days. 4. Return all affected product from your distributorship and affected hospitals within your territory along with a completed Attachment 1  Inventory Return Certification Form to Zimmer Biomet within 2 weeks (January 20, 2017). a. Request a Return Authorization Number via email to rgarequest@zimmerbiomet.com. Be sure to specify RECALL as the RGA type. b. For each return, send a copy of Attachment 1 to corporatequality.postmarket@zimmerbiomet.com. c. Include a hardcopy of Attachment 1 with your shipment for immediate processing. d. Mark the outside of the returns box(es) clearly with RECALL. 5. Note that any hospitals that received direct shipments of this product from Zimmer Biomet or were consigned products will be sent a copy of the Risk Manager Recall Notice directly. It is important that you review the list of hospitals included with the email notification sent to your facility to identify additional accounts Zimmer Biomet has not notified. Using the Additional Accounts Form provided with the email notice sent to your facility, return contact information for any additional hospitals from which you removed affected product. This form will be used to notify each account. If there are no addit
Quantity in Commerce 15,000
Distribution NATIONWIDE US ARGENTINA AUSTRALIA AUSTRIA BRAZIL CANADA CHILE CHINA COSTA RICA ECUADOR GREECE INDIA ITALY JAPAN KOREA, THE REP OF (SOUTH) MALAYSIA MEXICO NETHERLANDS PANAMA POLAND SINGAPORE THAILAND
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = BIOMET, INC.
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