Recall Z-1757-2015 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Biomet, Inc.
Biomet Cobalt-Chrome Femoral Components, 32MM MOD HEAD COCR -6MM NECK; 32MM MOD HEAD COCR -3 MM NECK; 32MM MOD HEAD COCR STD NECK ; 32MM MOD HEAD COCR +3MM NECK; 32MM COCR MOD HD +6MM NO SKIRT Hip joint replacement components include: femoral stems, femoral heads, acetabular shells, and acetabular liners.
| Date | Jun 11, 2015 (initiated Apr 16, 2015) |
| Status | Terminated |
| Reason | Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes. |
| Root cause | Labeling mix-ups |
| Action | Biomet sent an Urgent Medical Device Recall Notice letter dated April 29, 2015 to affected customers via Fed-Ex. The letter identifed the affected product, problem and actions to be taken. Customers were asked to complete the attached response form and return it along with recalled product to Biomet. For questions callt (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m. |
| Quantity | 1315 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K911684 | BIOMET COBALT-CHROME FEMORAL COMPONENTS Biomet, Inc., Jun 27, 1991 |