Biomet, Inc.: Medical Device Recall in 2020 - (Recall #: Z-0627-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.
Product Description:

RINGLOC ACETABULAR SYSTEM Self-tapping bone screws, Item numbers 103531, 103533, 103534, 103535 - Product Usage: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented; Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component); Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer.

Product Classification:

Class II

Date Initiated: November 25, 2020
Date Posted: December 23, 2020
Recall Number: Z-0627-2021
Event ID: 86896
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.

Status: Terminated
Product Quantity: 7428
Code Information:

Lots 259830 259860 259880 259890 259910 259920 260020 260140 260160

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

Voluntary or Mandated:

Voluntary: Firm initiated