Recall Z-1757-2015

Biomet, Inc. · initiated April 16, 2015

Class III Terminated

Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws

Product

Biomet 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.

Codes / lots: 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

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: Labeling mix-ups

Action taken

Biomet 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.

Details

Recall number
Z-1757-2015
Initiated
April 16, 2015
Posted by FDA
June 11, 2015
Terminated
May 16, 2016
Product code
JDI – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Quantity
1315
Distribution
Worldwide 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.
Recalling firm
Biomet, Inc., Warsaw, IN

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-1754-2015 Class IIIMallory/Head Primary Hip System; Size 11, 160 mm, Lateralized Femoral Stem; Ti-6Al-4V…Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect… 04/16/2015Terminated
Z-1755-2015 Class IIIComprehensive Shoulder System, 4 mm, 122 mm long, Primary Shoulder Stem, Ti-6Al-4V…Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect… 04/16/2015Terminated
Z-1756-2015 Class IIIMCK Maximum Congruent Knee System, BIOMET FINNED PRI STEM 40MM; 80 x 10MM; 80 x 12.5 MM…Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect… 04/16/2015Terminated