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Recall Observatory FDA recall evidence

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

April 16, 2015

Class III

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

    reason.labeling_packaging · v1.0.0

    labeling contains incorrect