Recall Z-1243-2014 ยท LXH Orthopedic Manual Surgical Instrument
Biomet, Inc.
Part 475625, Intramedullary Bone Saw, Cam Assembly Size 13 mm, The Biomet Intramedullary Bone Saw is a unique and exclusive clinical instrument that is used to correct leg length, or rotational discrepancies in the femur.
| Date | Mar 20, 2014 (initiated Feb 26, 2014) |
| Status | Terminated |
| Reason | Incorrect labeling on specific lots of the Intramedullary Bone Saw. The Saw Blade Assembly was identified as CAM Assembly. |
| Root cause | Labeling False and Misleading |
| Action | The firm, BIOMET, sent an "URGENT MEDICAL DEVICE SAFETY ALERT" letter dated February 26, 2014 via Fed Ex overnight to domestic consignees. Australia and GSCC were notified by email and also received a hard copy letter via mail. The letter described the product, problem and actions to be taken. The letter stated that this action requires the immediate location and discontinued use of the product and its return to Biomet. The Consignees were were instructed to immediately locate, discontinue use of the product and remove the identified device(s) listed; carefully follow the instructions on the |
| Quantity | 10 |
| Distribution | Worldwide Distribution: US (nationwide) to states of: NY, TX, MI, and M; to countries of: Australia and The Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.