Recall Z-1129-2019— DePuy Orthopaedics, Inc.
Class II · Terminated
Class II FDA medical device recall by DePuy Orthopaedics, Inc., initiated 2018-09-21, terminated 2020-04-22. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: There is the potential for debris/material to be found behind the O-rings in the neck trials..
- Recalling firm
- DePuy Orthopaedics, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-09-21
- Terminated
- 2020-04-22
- Firm location
- Warsaw, IN, United States
Product description
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.
Reason for recall
There is the potential for debris/material to be found behind the O-rings in the neck trials.
Data sourced from openFDA. This site is unofficial and independent of the FDA.