FDA-Device2020-12-23Class II
RINGLOC BIPOLAR Hip System Bi Polar Locking Ring, Item number 11-165304 - Product Usage: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate, Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented, Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented.
Biomet, Inc.
Hazard
Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Sold states
Worldwide distribution. US nationwide, ARGENTINA, AUSTRALIA, Brazil, CANADA, CHILE, CHINA, COSTA RICA, EMEA, HONG KONG, INDIA, JAPAN, KOREA, MALAYSIA, NEW ZEALAND, SINGAPORE, and TAIWAN
Affected count
7428
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
Products
RINGLOC BIPOLAR Hip System Bi Polar Locking Ring, Item number 11-165304 - Product Usage: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate, Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented, Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0628-2021Don't want to check this manually?
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