Biomet, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1754-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class III

Date Initiated: April 16, 2015

Date Posted: June 17, 2015

Recall Number: Z-1754-2015

Event ID: 71171

Reason for Recall:

Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes.

Status: Terminated

Product Quantity: 1315

Code Information:

Part Numbers: 11-104212 & 11-104211;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.

Voluntary or Mandated:

Voluntary: Firm initiated