DePuy Orthopaedics Recalls CORAIL AMT COXA VARA Neck Segments
DePuy Orthopaedics is recalling CORAIL AMT COXA VARA Neck Segments because debris or material may be found behind the O-rings.
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 3/5 (High).
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 involves a medical device with a potential for debris, which poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling CORAIL AMT COXA VARA Neck Segments (Pro. Code L20432). These surgical instruments are used in CORAIL total and partial hip arthroplasty. The recall involves 12,639 units that were distributed nationwide in the United States and internationally.
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 affected products are identified by specific lot codes listed in the official recall documentation.
Healthcare providers and facilities that have received these products should stop using them and contact DePuy Orthopaedics for further instructions on how to handle the affected units.
The recalled product
- Product
- CORAIL AMT COXA VARA NECK SEGMENT (KLA) Pro. Code L20432 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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