Recall Z-1000-2020— Zimmer Biomet, Inc.

Name: FDA recall Z-1000-2020
Creator: U.S. Food and Drug Administration
Published: 2019-12-12

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2019-12-12, terminated 2021-01-13. It names one FDA 510(k) clearance: K001989. Product: Coonrad/Morrey Total Elbow Humeral Assembly, Extra Small, 4-inch Length. Model No. 32-8105-027-04. UDI (01)00889024274006 (17)241031(10)64481139 The device is a Humeral component; elbow joint metal/polymer constrained cemented prosthesis.. Reason: The lot contained two outer pins instead of one outer and one inner pin..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-12-12
Terminated: 2021-01-13
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K001989 — COONRAD/MORREY TOTAL ELBOW. MODEL 32-8105 SERIESZimmer, Inc.·cleared 2000-07-25

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

Coonrad/Morrey Total Elbow Humeral Assembly, Extra Small, 4-inch Length. Model No. 32-8105-027-04. UDI (01)00889024274006 (17)241031(10)64481139 The device is a Humeral component; elbow joint metal/polymer constrained cemented prosthesis.

Reason for recall

The lot contained two outer pins instead of one outer and one inner pin.

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