Device product
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.
Z-1755-2015
Product summary
- Firm
- Biomet, Inc.
- Event
- Event 71171
- Status
- Terminated
- Classification
- Class III
- Quantity
- 2
- Official record key
device-enforcement:Z-1755-2015
Official wording
Reason: Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes.
Code information: Part Numbers: 113644; Use-by 2025-03-18; Lot Numbers: 127340, 182030, 349650.
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.
Derived failure modes
-
Labeling or packaging
labeling contains incorrect