Z-1754-2015 Class III Terminated
FDA device recall Z-1754-2015 was initiated by Biomet, Inc. on Apr 16, 2015 and is designated Class III. Reason for recall: Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes. The recall status is terminated (terminated May 16, 2016). Affected quantity: 1315.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 17, 2015
- Initiation Date
- Apr 16, 2015
- Termination Date
- May 16, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1315
Product Description
Mallory/Head Primary Hip System; Size 11, 160 mm, Lateralized Femoral Stem; Ti-6Al-4V; Porous Plasma Uncemented, & Mallory/Head Total Hip System Size 12, 165 mm, Bi- Metric Femoral Components. Hip joint replacement components include: femoral stems, femoral heads, acetabular shells, and acetabular liners.
Reason for Recall
Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes.
Distribution Pattern
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.
Code Information
Part Numbers: 11-104212 & 11-104211;Use-by 2025-03-18; Lot Numbers: 127340, 182030, 349650.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1754-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026