DePuy CORAIL Neck Trials Recalled for Potential Debris Behind O-rings
DePuy Orthopaedics is recalling CORAIL AMT Standard Offset Neck Segments because debris or material may be found behind the O-rings. These surgical instruments are used in hip arthroplasty.
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 the hazard involves a risk-of-harm product (surgical instrument) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling the CORAIL AMT Standard Offset Neck Segment (STD), Product Code L20431. The recall involves 12,639 units of these surgical instruments, which are used in CORAIL total and partial hip arthroplasty procedures.
The recall was initiated because there is the potential for debris or material to be found behind the O-rings in the neck trials. The affected products were distributed nationwide in the United States to accounts in 32 states and internationally worldwide.
Healthcare providers and patients should contact DePuy Orthopaedics for further instructions regarding the recall and replacement of these devices.
The recalled product
- Product
- CORAIL AMT STANDARD OFFSET NECK SEGMENT (STD), Pro. Code L20431 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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