Recall Z-2300-2020— Biomet, Inc.

Name: FDA recall Z-2300-2020
Creator: U.S. Food and Drug Administration
Published: 2020-05-11

Class II · Terminated

Class II FDA medical device recall by Biomet, Inc., initiated 2020-05-11, terminated 2020-11-04. It names one FDA 510(k) clearance: K152754. Product: Comprehensive VRS Inserter, shoulder prosthesis, Item No. 110019068. UDI: (01)00880304829503 (10)814100, (01)00880304829503 (10)570640, (01)00880304829503 (10)728890, (01)00880304829503 (10)977300. Reason: The product is being recalled due to the central screw drill seizing inside the Comprehensive VRS Inserter, which may lead to an extension of surgery to find a replacement device..

Recalling firm: Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-05-11
Terminated: 2020-11-04
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K152754 — COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS)Biomet Manufacturing Corp·cleared 2016-05-16

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 VRS Inserter, shoulder prosthesis, Item No. 110019068. UDI: (01)00880304829503 (10)814100, (01)00880304829503 (10)570640, (01)00880304829503 (10)728890, (01)00880304829503 (10)977300

Reason for recall

The product is being recalled due to the central screw drill seizing inside the Comprehensive VRS Inserter, which may lead to an extension of surgery to find a replacement device.

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