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U.S. Department of Health and Human Services

Class 3 Device Recall BIOMET

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 Class 3 Device Recall BIOMETsee related information
Date Initiated by FirmApril 16, 2015
Date PostedJune 11, 2015
Recall Status1 Terminated 3 on May 16, 2016
Recall NumberZ-1757-2015
Recall Event ID 71171
510(K)NumberK911684 
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
ProductBiomet Cobalt-Chrome Femoral Components, 32MM MOD HEAD COCR -6MM NECK; 32MM MOD HEAD COCR -3 MM NECK; 32MM MOD HEAD COCR STD NECK ; 32MM MOD HEAD COCR +3MM NECK; 32MM COCR MOD HD +6MM NO SKIRT Hip joint replacement components include: femoral stems, femoral heads, acetabular shells, and acetabular liners.
Code Information Part Numbers: 163667; 163668; 163669; 163670; 163674; Use-by 2025-03-18; Lot Numbers: 331620; 331650; 453080; 453090; 453110; 453120; 489140; 453180; 471380; 471410; 044600; 332720; 375590; 375620; 375630; 375640; 375650; 465840; 466050; 470060; 471430; 471440; 471450; 375660; 375670; 375700; 453220 
Recalling Firm/
Manufacturer
Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information ContactAudrey Daenzer
800-348-9500 Ext. 1570
Manufacturer Reason
for Recall
Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes.
FDA Determined
Cause 2
Labeling mix-ups
ActionBiomet sent an Urgent Medical Device Recall Notice letter dated April 29, 2015 to affected customers via Fed-Ex. The letter identifed the affected product, problem and actions to be taken. Customers were asked to complete the attached response form and return it along with recalled product to Biomet. For questions callt (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.
Quantity in Commerce1315
DistributionWorldwide Distribution - US Nationwide in the states of AR, CA, IL, IN, PA, FL, KS, LA, WI, VA, MA, MD, NJ, UT, NC, TX, AL, MI, KY, OH, SD, MO, GA, NV, WA and the countries of: Europe, Canada, Japan, Chile, Korea, Mexico, New Zealand, Trinidad/Tobago, Thailand, Argentina, Australia, and China.
Total Product Life CycleTPLC 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.
510(K) Database510(K)s with Product Code = JDI
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