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.
Recall
- Recall Number
- Z-1127-2019
- Event Number
- 82353
- Firm
- DePuy Orthopaedics, Inc.
- FEI Number
- 1818910
- Product Code
- LXH
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- September 21, 2018
- Terminated
- April 22, 2020
- Address
- 700 Orthopaedic Dr, Warsaw, IN, 46582-3994
Description
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.
There is the potential for debris/material to be found behind the O-rings in the neck trials.
On September 21, 2018, the firm notified customers via email that rework was required for the affected product. Customers were advised that the three affected product codes were produced with an O-Ring until a 2010 design change removed the O-Ring as a rolling change. Customers were provided with work instructions for how to rework the product by removing the O-Ring. Please Take the Following Urgent Actions: 1. Please continue to follow the instructions for use in IFU-W90946 Rev B regarding cleaning of these devices. 2. Immediately review your inventory and rework the affected units. Your DePuy Synthes Sales Consultant can assist with the rework. o Reconciliation Form: Complete the reconciliation form and return to your sales consultant or fax to 574-371-4939 or email to [email protected] within five (5) days of this notice. o Records: Retain a copy of the completed reconciliation form in your files along with this notice. 3. Additional Notifications: o Notify surgeons at your facility by providing them with a copy of this notice. Forward this notice to others in your facility that need to be informed. For product-related questions, please contact your local DePuy Orthopaedics, Inc. Sales Consultant. For clinical questions from surgeons, please contact DePuy Orthopaedics, Inc.s Scientific and Medical Affairs mailbox [email protected]. For questions about the information provided, please contact Kim Earle, Senior Recall Coordinator, at 574-371-4917 (M-F; 8 a.m. 5 p.m. EDT).
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.
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