Anspach REF: TURQ-434-4 Twist Drill for 1.5mm x 4mm screw. Rx only Single use Sterile bone cutting burs.
FDA device recall Z-0830-2014 · posted 2014-01-27 · Terminated
Recall details
- Recalling firm
- The Anspach Effort, Inc.
- Reason for recall
- Cutter was longer than was stated on the label
- Action taken
- Anspach sent an Urgent Medical Device Product Removal letter dated March, 32, 2013, to all affeced customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inventory their batches and return the products for replacement. Customers needing assistance were instructed to contact Anspach at 800-327-6887. For questions regarding this recall, call 800-327-6887.
- Root cause
- Pending
- Status
- Terminated
- Product code
- GFF
- Quantity affected
- 29 cutting burs
- Distribution
- Worldwide Distribution - USA including CA, CO, IN, KY, MD and TX and Internationally to Japan, Taiwan, United Kingdom, Sweden, and Germany.
- Date initiated
- 2011-03-31
- Date posted
- 2014-01-27
- Date terminated
- 2019-07-18
- 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 |