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U.S. Department of Health and Human Services

Class 1 Device Recall Biomet Comprehensive Reverse Shoulder Humeral

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  Class 1 Device Recall Biomet Comprehensive Reverse Shoulder Humeral see related information
Date Initiated by Firm December 20, 2016
Create Date February 11, 2017
Recall Status1 Open3, Classified
Recall Number Z-1103-2017
Recall Event ID 75971
510(K)Number K080642  
Product Classification prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented - Product Code PAO
Product Comprehensive Reverse Shoulder System Humeral Tray
Model 115340
Code Information Lot numbers, 041870, 041880, 041890, 052860, 060500, 070330, 079900, 085130, 118250, 118260, 118270, 118280, 118290, 118300, 118340, 118350, 118360, 118370, 118380, 118390, 132020, 132030, 153330, 153340, 153350, 153360, 153370, 153380, 153390, 153400, 153410, 153420, 153430, 159650, 159660, 161960, 172670, 215990, 216000, 216010, 256990, 257000, 257010, 257020, 278300, 278310, 278320, 278330, 278550, 278560, 278580, 278590, 300090, 300100, 300110, 300120, 300130, 300140, 300150, 310580, 310590, 310600, 310610, 310620, 329390, 349140, 349150, 351030, 351040, 367300, 367310, 367320, 367330, 367340, 367350, 367360, 367370, 367380, 372290, 372310, 372320, 385090, 402880, 411980, 413530, 415040, 415050, 415060, 415070, 415080, 415090, 420630, 424640, 424650, 424660, 424670, 424680, 424690, 424700, 424710, 424720, 424730, 424740, 436760, 436770, 440500, 457900, 492370, 492380, 492390, 492400, 492410, 492420, 492430, 492440, 492450, 501830, 551660, 556800, 556820, 557440, 557620, 557840, 558840, 558880, 558890, 558900, 558910, 558920, 561910, 562430, 563440, 568870, 569050, 569060, 569070, 569080, 569090, 569100, 569120, 569130, 569140, 569150, 569690, 578920, 595090, 597740, 607390, 607400, 607410, 607420, 607430, 609780, 613990, 630660, 633600, 634660, 634860, 635190, 637190, 637240, 641220, 641350, 641390, 641680, 648790, 648800, 648810, 648820, 648830, 648860, 659950, 659960, 659970, 659980, 659990, 660000, 660010, 660020, 660030, 660040, 668550, 668560, 668570, 668580, 668590, 668600, 668610, 668620, 668630, 668970, 674320, 677090, 677100, 677110, 677140, 677150, 677160, 677170, 677180, 677190, 677200, 680720, 680730, 680740, 680750, 680760, 697100, 697110, 697120, 697130, 697150, 697160, 697170, 697180, 697190, 697200, 704050, 704810, 706840, 712090, 715990, 716200, 723830, 723850, 723870, 723880, 725550, 725560, 725760, 726590, 726710, 734810, 745350, 762930, 764700, 765560, 765830, 765870, 767360, 767370, 771810, 788670, 788680, 788690, 791260, 791270, 791280, 818790, 839150, 846190, 846200, 846210, 846230, 846240, 846280, 846290, 846300, 846310, 846320, 846330, 848110, 848120, 848130, 848140, 848150, 848160, 848170, 848190, 848200, 848210, 848220, 848230, 848240, 848250, 848260, 848270, 848280, 848290, 848300, 848310, 848320, 854210, 854220, 854240, 854250, 854260, 854290, 854300, 854310, 854320, 863330, 889690, 908010, 950390, 950400, 963700, 974990, 981260, 981270.
Recalling Firm/
Manufacturer
Zimmer Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact 411 Technical Services
574-371-3071
Manufacturer Reason
for Recall
Higher than anticipated rate of fracturing due to design. Risk of revision surgery due to fracturing.
FDA Determined
Cause 2
Device Design
Action On 12/20/2016, URGENT MEDICAL DEVICE RECALL-LOT SPECIFIC notifications were sent to the affected Risk Managers and Distributors 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. Risk Manager Responsibilities: 1. Review this notification and ensure affected personnel are aware of the contents. 2. Assist your Zimmer Biomet sales representative quarantine all affected product. 3. Your Zimmer Biomet sales representative will remove the affected product from your facility. 4. Complete Attachment 1  Certificate of Acknowledgement. a. Return a digital copy within three (3) days to corporatequality.postmarket@zimmerbiomet.com. b. Retain a copy of the Acknowledgement Form with your recall records in the event of a compliance audit of your facilities documentation. 5. If after reviewing this notice you have further questions or concerns please call 411 Technical Services at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of the call center operating hours will receive a prompt to record a voice mail or be transferred to an on-call representative in the case of an emergency. Alternatively, your questions may be sent by email to corporatequality.postmarket@zimmerbiomet.com. Distributor Responsibilities 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. Immediately return all affected product from your distributorship and affected hospitals within your territory along with a completed Attachment 1  Inventory Return Certification Form
Quantity in Commerce 268
Distribution Nationwide. CANADA AUSTRALIA CHILE COLOMBIA KOREA Netherlands
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 = PAO and Original Applicant = BIOMET, INC.
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