Recall Z-0830-2014 ยท GFF Bur, Surgical, General & Plastic Surgery
The Anspach Effort, Inc.
Anspach REF: TURQ-434-4 Twist Drill for 1.5mm x 4mm screw. Rx only Single use Sterile bone cutting burs.
| Date | Jan 27, 2014 (initiated Mar 31, 2011) |
| Status | Terminated |
| Reason | Cutter was longer than was stated on the label |
| Root cause | Pending |
| Action | 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |