Recall Z-1131-2021— Biomet, Inc.

Name: FDA recall Z-1131-2021
Creator: U.S. Food and Drug Administration
Published: 2021-01-15

Class II · Terminated

Class II FDA medical device recall by Biomet, Inc., initiated 2021-01-15, terminated 2023-03-09. It names one FDA 510(k) clearance: K132239. Product: Central Screw 6.5x25mm - Product Usage: used as a sterile screw that is intended for implantable shoulder prosthesis assembly and/or fixation.. Reason: Zimmer Biomet is conducting a lot specific medical device recall for the Comprehensive Reverse Shoulder Central Screw, 25 MM Length. It has been determined through a complaint investigation that a 40 MM length central screw was packaged and labeled as a 25 MM length central screw..

Recalling firm: Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-01-15
Terminated: 2023-03-09
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K132239 — COMPREHENSIVE REVERSE SHOULDER SCREWSBiomet Manufacturing Corp·cleared 2013-09-06

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

Central Screw 6.5x25mm - Product Usage: used as a sterile screw that is intended for implantable shoulder prosthesis assembly and/or fixation.

Reason for recall

Zimmer Biomet is conducting a lot specific medical device recall for the Comprehensive Reverse Shoulder Central Screw, 25 MM Length. It has been determined through a complaint investigation that a 40 MM length central screw was packaged and labeled as a 25 MM length central screw.

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