DePuy Orthopaedics Recalls CORAIL COXA VARA High Offset Stem Due to Packaging Error
DePuy Orthopaedics is recalling 21 units of CORAIL COXA VARA High Offset Stem because the packages contained the wrong device model.
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 and involves a packaging error where the wrong device was shipped. The rubric classifies minor labeling errors and voluntary precautionary recalls as Moderate (Score 2).
Plain-English summary
DePuy Orthopaedics, Inc. is recalling 21 units of the CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9 (Part No. 3L93709, Lot No. 5291990). The recall was initiated because the packages were labeled for the CORAIL COXA VARA model but actually contained the CORAIL HIGH OFFSET STEM Collarless SIZE 14 (Part No. L20314, Lot No. 5292130).
The affected devices were distributed nationally to US distributors and medical facilities, including hospitals and user facilities, that may have purchased, used, or received the device. This is classified as an FDA Class II recall.
Healthcare providers and distributors should stop using the affected devices and contact DePuy Orthopaedics for instructions on how to return or replace the product.
The recalled product
- Product
- CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9
- Manufacturer
- DePuy Orthopaedics, Inc.
- Hazard
- Affected units
- 21
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)
- Part No. 3L93709 and Lot No. 5291990
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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