DePuy Orthopaedics Recalls DELTA XTEND Reverse Shoulder System Implants
DePuy Orthopaedics is recalling DELTA XTEND Reverse Shoulder System implants because the epiphysis may not assemble to the stem, potentially causing surgical delays.
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 2/5 (Moderate).
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. The hazard is a potential surgical delay due to assembly failure, with no reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling DELTA XTEND Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants. These devices are intended for use in total shoulder or hemi-shoulder replacement procedures in patients with non-functional rotator cuffs. The affected lots were distributed nationally.
The recall is being conducted because the epiphysis may not assemble to the stem. This defect may cause a surgical delay. The source text does not report any injuries, illnesses, or deaths associated with this issue.
Healthcare providers and patients should contact DePuy Orthopaedics for further instructions regarding the affected lots. The recall covers specific lot codes identified in the official FDA record Z-0834-2018.
The recalled product
- Product
- DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants intended for use in total shoulder or hemi-shoulder replacement procedures in patients with non-functional rotator cuffs. HA components are for cementless use only.
- Manufacturer
- DePuy Orthopaedics, Inc.
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by DePuy Orthopaedics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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