Zimmer Biomet Recalls Coonrad/Morrey Total Elbow Humeral Assembly Due to Pin Error
Zimmer Biomet is recalling three units of the Coonrad/Morrey Total Elbow Humeral Assembly because the lot contained two outer pins instead of one outer and one inner pin.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a structural defect in a medical device (incorrect pin configuration) which poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Zimmer Biomet, Inc. is recalling three units of the Coonrad/Morrey Total Elbow Humeral Assembly, Extra Small, 4-inch Length (Model No. 32-8105-027-04, Lot 64481139). The device is a humeral component for an elbow joint metal/polymer constrained cemented prosthesis.
The recall was initiated because the specific lot contained two outer pins instead of the required one outer and one inner pin. This manufacturing error affects the structural configuration of the device.
The affected units were distributed to accounts in California and Ohio. No specific consumer action is detailed in the source text beyond the recall notification.
The recalled product
- 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.
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 3
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot 64481139
Distribution
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