Anspach Single Use, Sterile Bone Cutting Burrs
FDA device recall Z-1008-2007 · posted 2007-07-11 · Terminated
Recall details
- Recalling firm
- The Anspach Effort, Inc.
- Reason for recall
- The white film portion of the sterile pouch may become brittle prior to the expiry date compromising the sterility of the product.
- Action taken
- The firm issued a recall letter on May 18, 2007, to its consignee, advising them of the recall. Consignees were asked to screen their inventory for the recalled devices and complete an accompanying product replacement form. The firm will replace all returned product within 30 days.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- HBB
- Quantity affected
- 1,962,123
- Distribution
- World wide-Distributed throughout the United States and to Puerto Rico, Canada, Mexico, Japan, Lithuania, Cyprus, Austrailia, England, Sweden, Bahamas, Korea, Germany, Switzerland, Malaysia, Iceland,
- Date initiated
- 2007-05-18
- Date posted
- 2007-07-11
- Date terminated
- 2009-01-17
- Location
- Palm Beach Gardens, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM (K061297) | The Anspach Effort, Inc. | 2007-01-26 |
| ANSPACH EMAX DRILL SYSTEM (K011444) | The Anspach Effort, Inc. | 2001-08-08 |
| ANSPACH MICROMAX SYSTEM (K965080) | The Anspach Effort, Inc. | 1997-01-10 |
| ASPACH 65,000 (MODIFICATION) (K955084) | The Anspach Effort, Inc. | 1996-01-17 |