Recall Z-1750-2020— Biomet, Inc.

Name: FDA recall Z-1750-2020
Creator: U.S. Food and Drug Administration
Published: 2020-03-13

Class II · Terminated

Class II FDA medical device recall by Biomet, Inc., initiated 2020-03-13, terminated 2021-07-21. It names one FDA 510(k) clearance: K080642. Product: Comprehensive Humeral Tray Taper Extraction Pliers - Replacement Tips, Model Number 110028522 - Product Usage: Intended to be used in surgery to relieve pain and to replace the glenoid and humeral side of the shoulder joint in order to restore mobility in a grossly rotator cuff deficient joint with severe arthropathy or a previous joint replacement with a grossly rotator cuff deficient joint.. Reason: There were unknown bioburden levels prior to sterilization, which may affect sterility of the product..

Recalling firm: Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-03-13
Terminated: 2021-07-21
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K080642 — COMPREHENSIVE REVERSE SHOULDERBiomet, Inc.·cleared 2008-07-09

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

Comprehensive Humeral Tray Taper Extraction Pliers - Replacement Tips, Model Number 110028522 - Product Usage: Intended to be used in surgery to relieve pain and to replace the glenoid and humeral side of the shoulder joint in order to restore mobility in a grossly rotator cuff deficient joint with severe arthropathy or a previous joint replacement with a grossly rotator cuff deficient joint.

Reason for recall

There were unknown bioburden levels prior to sterilization, which may affect sterility of the product.

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