Anspach Carbide Cutting Burrs: 2MM Carbide Fluted Ball, Standard, 8 Flutes - part #QD8-2SB-C-8F, 4MM Carbide Fluted Ball
FDA device recall Z-0726-2014 · posted 2014-01-13 · Terminated
Recall details
- Recalling firm
- The Anspach Effort, Inc.
- Reason for recall
- Some carbide cutting burr fractured during use.
- Action taken
- The firm, Anspach, sent an "URGENT: MEDICAL DEVICE REMOVAL" letter dated December 19, 2013 to their costumers. The letter described the product, problem and actions to be taken. The customers were instructed to complete the attached reply form confirming your receipt of this letter and return the completed form by Fax to: 1-800-327-6661 or Email: customer.support@synthes.com. Reference RMA 200059216 when returning any devices. If you distribute(d any of the products to other services or facilities, please forward this information as appropriate . Should you have any queries please do not hesitate to contact Anspach Customer Support at 800-327-6887 or e-mail at customer.support@synthes.com.
- Root cause
- Process design
- Status
- Terminated
- Product code
- HBE
- Quantity affected
- 28,562 total of all products in this recall
- Distribution
- Worldwide distribution: US (Nationwide) including state of Hawaii and Internationally to: Australia, Poland, Canada, South Africa, Israel, and Switzerland.
- Date initiated
- 2013-12-17
- Date posted
- 2014-01-13
- Date terminated
- 2016-05-09
- Location
- Palm Beach Gardens, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EMAX 2 PLUS SYSTEM, MODEL EMAX 2 PLUS MOTOR, EMAX 2 CONSOLE>FIRMWARE UPGRADE, EMAX 2 FP FOOT PEDAL (K080802) | The Anspach Effort, Inc. | 2008-04-30 |