Recall Z-1129-2019 ยท LXH Orthopedic Manual Surgical Instrument
DePuy Orthopaedics, Inc.
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.
| Date | Sep 21, 2018 |
| Status | Terminated |
| Reason | There is the potential for debris/material to be found behind the O-rings in the neck trials. |
| Root cause | Nonconforming Material/Component |
| Action | 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 De |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.