Z-1755-2015 Class III Terminated
FDA device recall Z-1755-2015 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: 2.
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
- 2
Product Description
Comprehensive Shoulder System, 4 mm, 122 mm long, Primary Shoulder Stem, Ti-6Al-4V, Standard Length Porous Plasma. Shoulder joint replacement components include humeral stems, humeral heads, and glenoid components.
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: 113644; 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-1755-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026