ANSPACH Cutting bur, 3 mm Diamond Ball, Standard Length. REF L-3SD Use with LONG Attachments. Used for cutting and shapi
FDA device recall Z-1574-2014 · posted 2014-05-09 · Terminated
Recall details
- Recalling firm
- The Anspach Effort, Inc.
- Reason for recall
- Anspach product code L-3SD contained product code S-3SD which is shorter in length than the labeled product.
- Action taken
- Anspach sent an "URGENT: MEDICAL DEVICE REMOVAL" letter dated January 13, 2014, to all affected customers. The letter described the product, the problem and actions to be taken. If they have distributed any of the products to other services or facilities, customers were instructed to please forward this information as appropriate. Customers with questions you contact Anspach Customer Support at (800) 327-6887, option 3 or email customer.support@synthes.com.. Customers were asked to complete the attached reply form confirm receipt of the letter, return the completed form by fax to 800-327-6661. For questions regarding this recall call 561-494-3706.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- HTT
- Quantity affected
- 30 cutting burs affected
- Distribution
- Nationwide Distribution including FL, TX, NC, IL, CO, and PA.
- Date initiated
- 2014-01-08
- Date posted
- 2014-05-09
- Date terminated
- 2015-01-20
- 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 |