Ultra Power Burs, Sterile, Single-Use.
FDA device recall Z-0041-05 · posted 2004-10-23 · Terminated
Recall details
- Recalling firm
- Linvatec Corp.
- Reason for recall
- The pouch containing the sterile product is not completely seal on all products. Therefore , the sterility of the device is questionable.
- Action taken
- 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.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- HRX
- Quantity affected
- 58510 units
- Distribution
- Distributed to 492 customers throughout the United States, and 301 customers internationally.
- Date initiated
- 2004-08-26
- Date posted
- 2004-10-23
- Date terminated
- 2012-07-06
- Location
- Largo, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTEGRATED DRIVE/PUMP SYSTEM (K981636) | Linvatec Corp. | 1998-08-20 |
| SURGAIRTOME TWO (K781979) | American Sterilizer Co. | 1978-12-20 |