Z-0628-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 23, 2020
- Initiation Date
- November 25, 2020
- Termination Date
- May 8, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7428
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Worldwide distribution. US nationwide, ARGENTINA, AUSTRALIA, Brazil, CANADA, CHILE, CHINA, COSTA RICA, EMEA, HONG KONG, INDIA, JAPAN, KOREA, MALAYSIA, NEW ZEALAND, SINGAPORE, and TAIWAN
Code Information
Lot 173500