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.
Reported: April 17, 2019 Initiated: September 21, 2018 #Z-1128-2019
Product Description
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.
Reason for Recall
There is the potential for debris/material to be found behind the O-rings in the neck trials.
Details
- Recalling Firm
- DePuy Orthopaedics, Inc.
- Units Affected
- 12639 total
- Distribution
- Worldwide Distribution - US Nationwide Distributed to accounts in AL AZ CA CO FL GA HI IA IL IN KY LA MA MD ME MI MN MS NC ND NH NJ NV NY OH OR PA SC TN TX UT VA WA, and WI. International distribution worldwide.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by DePuy Orthopaedics, Inc.. Units affected: 12639 total.
Why was this product recalled? ▼
There is the potential for debris/material to be found behind the O-rings in the neck trials.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 17, 2019. Severity: Moderate. Recall number: Z-1128-2019.
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