***REF S-3D*** 3mm Diamond Ball. Used for cutting and shaping bone.
FDA device recall Z-1377-2013 · posted 2013-05-24 · Terminated
Recall details
- Recalling firm
- The Anspach Effort, Inc.
- Reason for recall
- Due to three batches of product may have diamond grit size larger than intended applied to the head of the cutting burr.
- Action taken
- Anspach sent an URGENT: Medical Device Correction letter dated March 4, 2011 to its customers identifying the affected product and actions to be taken by the customers. Customers questions or concerns should be directed to Anspach Customer Support at (800) 327-6887.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- HBE
- Quantity affected
- 1,827 burrs
- Distribution
- Worldwide Distribution-USA (nationwide) including DC and the states of OH, TX, IL, CA, GA, KY, FL, WI, NC, VA, WI, MN, MD, KS, OK, PA, OR ,HI, AZ, WA, TN, AR, IA, MI, CO, LA, NJ, IN, WV, MO, AL, NY, V
- Date initiated
- 2011-03-04
- Date posted
- 2013-05-24
- Date terminated
- 2013-12-17
- 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 DISSECTION TOOLS (K113476) | The Anspach Effort, Inc. | 2011-12-16 |