Food, drugs, devices › Zimmer Biomet, Inc.
Device recall: Coonrad/Morrey Total Elbow Humeral Assembly, Extra Small, 4-inch Length. Model No. 32-8105-027-04. UDI (01)0088902427400
Zimmer Biomet, Inc. (Warsaw, IN) initiated this device recall on 12 Dec 2019; FDA lists 1 product record under event 84636, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 968 device enforcement events initiated in 2019 carry the same class.
Status: Terminated, terminated 13 Jan 2021. Initiation: voluntary: firm initiated. Zimmer Biomet, Inc. has 144 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Zimmer Biomet, Inc., Warsaw, IN.
Reason for recall
"The lot contained two outer pins instead of one outer and one inner pin."
Distribution
"Distributed to accounts in California and Ohio."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1000-2020 | 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. | 3 | Class II | Terminated | 12 Feb 2020 |
Context
Other enforcement events for Zimmer Biomet, Inc.
All 144 events for Zimmer Biomet, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The lot contained two outer pins instead of one outer and one inner pin."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Distributed to accounts in California and Ohio."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 13 Jan 2021. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.