Recall Z-0628-2021— Biomet, Inc.

Name: FDA recall Z-0628-2021
Creator: U.S. Food and Drug Administration
Published: 2020-11-25

Class II · Terminated

Class II FDA medical device recall by Biomet, Inc., initiated 2020-11-25, terminated 2024-05-08. It names one FDA 510(k) clearance: K051569. Product: 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: 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..

Recalling firm: Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-11-25
Terminated: 2024-05-08
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K051569 — RINGLOC BI-POLAR ACETABULAR COMPONENTBiomet, Inc.·cleared 2005-09-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.