Cutting Burr labeled in part:"***S-1504TD QTY:1***Twist Drill for 1.5 mm x 4 mm Screw. Use with SHORT Attachments.***ANS
FDA device recall Z-3202-2011 · posted 2011-09-14 · Terminated
Recall details
- Recalling firm
- The Anspach Effort, Inc.
- Reason for recall
- The Anspach Effort, Palm Beach Gardens, FL, is recalling their Single Use, Sterile Bone Cutting Burrs, Catalog #, S-1504TD, Lot #s D363039140. D323038110, D293037349 and Catalog # TURQ-434-4, Lot #s D343038845, D323038131, due to the burr being 2.0 mm longer than stated on the label. As a result, a hole drilled using this burr would be 2 mm deeper than the screw.
- Action taken
- Anspach Effort, Palm Beach Gardens, FL sent a Customer letter dated March 31, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers were instructed to screen their inventory, contact Anspach Customer Support at (800) 327-6887 if any of the recalled product was found, and complete and return the attached reply form. If the product had been further distributed, they were asked that the recall information be forwarded as appropriate.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- HBC
- Quantity affected
- 599
- Distribution
- Worldwide Distribution -- USA (nationwide) including the states of CA, CO, IN, KY, MD and TX. and the countries of Germany, Japan, Taiwan, United Kingdom and Sweden.
- Date initiated
- 2011-03-17
- Date posted
- 2011-09-14
- Date terminated
- 2011-10-11
- 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 EMAX DRILL SYSTEM (K011444) | The Anspach Effort, Inc. | 2001-08-08 |
| ANSPACH SHIELDED ATTACHMENT (K974025) | The Anspach Effort, Inc. | 1998-07-06 |