DePuy Orthopaedics Recalls DELTA XTEND Reverse Shoulder System Implants
DePuy Orthopaedics is recalling 23,053 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 stated hazard is a surgical delay due to assembly issues, which does not involve reported injuries, fatalities, or high-risk pathogens, fitting the criteria for a moderate severity score.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling 23,053 units of DELTA XTEND Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants. These implants are intended for use in total shoulder or hemi-shoulder replacement procedures in patients with non-functional rotator cuffs, with HA components designated for cementless use only.
The recall was initiated because the epiphysis may not assemble to the stem. This defect may cause a surgical delay. The affected lots were distributed nationally.
Healthcare providers should stop using the affected lots and contact DePuy Orthopaedics for further instructions. Patients who have already received these implants should consult their healthcare provider regarding the recall.
The recalled product
- Product
- DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants are 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.
- Affected units
- 23,053
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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