Recall Z-0041-05 ยท HRX Arthroscope
Linvatec Corp.
Ultra Power Burs, Sterile, Single-Use.
| Date | Oct 23, 2004 (initiated Aug 26, 2004) |
| Status | Terminated |
| Reason | The pouch containing the sterile product is not completely seal on all products. Therefore , the sterility of the device is questionable. |
| Root cause | Packaging process control |
| Action | Each consignee will be notified by telephone, email, letter or UPS overnight delivery. They will be asked to return the affected product to Linvatec, Largo, Florida for credit or no-cost replacement. A returned goods authorization number will be assigned for the returned product. |
| Quantity | 58510 units |
| Distribution | Distributed to 492 customers throughout the United States, and 301 customers internationally. |
| FDA record | Open on fda.gov |