Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0594-2018·Announced 2018-02-21

DePuy Orthopaedics Recalls CORAIL High Offset Stem Due to Incorrect Packaging

DePuy Orthopaedics is recalling 19 CORAIL High Offset Stem devices because they were packaged in a box labeled for a different size and type of stem.

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, but the source text describes a packaging/labeling error (incorrect device in package) without reporting any injuries, illnesses, or deaths. This aligns with the 'Moderate' criteria for labeling errors or low-risk contamination where no harm has been reported.

Plain-English summary

DePuy Orthopaedics, Inc. is recalling 19 units of the CORAIL HIGH OFFSET STEM Collarless SIZE 14 (Part No. L20314, Lot No. 5292130). The recall was initiated because these specific devices were found in a package that was incorrectly labeled as the CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9 (Part No. 3L93709, Lot No. 5291990).

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. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Healthcare providers and facilities should check their inventory for the specific part and lot numbers listed above. If the affected devices are found, they should be removed from service and returned to DePuy Orthopaedics, Inc. according to the company's instructions.

The recalled product

Product: CORAIL HIGH OFFSET STEM Collarless SIZE 14
Manufacturer: DePuy Orthopaedics, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: mis-labeling
packaging-error
Affected units: 19

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. L20314 and Lot No. 5292130

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.

See all 2 products in this recall →

Same manufacturer · DePuy Orthopaedics, Inc.

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Same hazard · mis labeling