The Recall Desk
ModerateFDA (Devices)·Z-1239-2018·Announced 2018-04-04

Zimmer Biomet Recalls Coonrad/Morrey Elbow Implant Humeral Assemblies

Zimmer Biomet is recalling nine Coonrad/Morrey Elbow Implant humeral assemblies because they are missing required humeral bushing components.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Zimmer Biomet, Inc. is recalling nine units of the Coonrad/Morrey Elbow Implant System humeral assembly, Item Number 32-8105-027-04. The specific lot number is 63694912. The recall was initiated because the humeral stem implants in this lot do not include the required humeral bushing components.

The affected products were distributed in China and Taiwan. The source text does not specify the number of patients implanted with these devices or report any illnesses or injuries associated with the missing components.

Consumers and healthcare providers should contact Zimmer Biomet, Inc. for further instructions regarding the return or replacement of these devices.

The recalled product

Product
Coonrad/Morrey Elbow Implant System humeral assembly 4IN XSML, Item Number: 32-8105-027-04 (UDI: (01)0088902427 4006(17)220731(10)63694912)
Affected units
9

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 Number: 63694912

Distribution

Distribution scope not specified by the agency.