Recall Z-0829-2011 ยท LXH Orthopedic Manual Surgical Instrument
Biomet, Inc.
Vanguard Knee Instruments offset reamer bushing - angled, REF 32-488519, Biomet Bridgend, UK. This instrument is used to prepare the tibial cancellous bone for the tibial offset tray.
| Date | Dec 28, 2010 (initiated Sep 10, 2010) |
| Status | Terminated |
| Reason | The firm has initiated the action following a report that during surgery the Offset Reamer Brushign would not mate with the prepartion mask. After a 5 minute delay in surgery the procedure was completed using another attachment that was on hand. There was no injury to the patient. |
| Root cause | Other |
| Action | The firm, BIOMET, sent a "FIELD SAFETY NOTICES" dated September 10, 2010, addressed to the head of orthopaedic departments, trauma departments, operating departments, sterile service departments, procurement, supplies and risk management. The notice described the product, problem and action to be taken by the customers. The letters instructed the customers to locate and immediately quarantine the recalled device; to complete and return the attached "FAX BACK RESPONSE FORM" via fax to +44 (0) 1656 645454, and the recalled device for credit via mail to Biomet UK Ltd, Waterton Industrial Estate, |
| Quantity | 16 units |
| Distribution | International distribution only: Netherlands, Germany, France, Spain, Italy and Denmark |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.