DePuy CORAIL AMT High Offset Neck Segment Recall for Potential Debris
DePuy Orthopaedics is recalling CORAIL AMT High Offset Neck Segments because debris or material may be found behind the O-rings.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (surgical instrument) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling the CORAIL AMT High Offset Neck Segment (KHO), Product Code L20433. These surgical instruments are used in CORAIL total and partial hip arthroplasty. The recall involves 12,639 units distributed nationwide in the United States and internationally worldwide.
The recall is being conducted because there is the potential for debris or material to be found behind the O-rings in the neck trials. The agency has classified this as a Class II recall. The source text does not report any specific illnesses, injuries, or deaths associated with this defect.
Healthcare providers and facilities should stop using the affected CORAIL Neck Trials and contact DePuy Orthopaedics for instructions on how to return or dispose of the devices. Patients who have had hip arthroplasty using these specific instruments should consult their healthcare provider if they have concerns.
The recalled product
- Product
- CORAIL AMT HIGH OFFSET NECK SEGMENT (KHO), Pro. Code L20433 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty.
- Manufacturer
- DePuy Orthopaedics, Inc.
- Hazard
- Affected units
- 12,639
Distribution
Part of a larger recall action
This product is one of 3 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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