ANSPACH Cutting bur, 3 mm Diamond Ball, Standard Length. REF L-3SD Use with LONG Attachments. Used for cutting and shaping bone, including the spine and cranium.
Recall
- Recall Number
- Z-1574-2014
- Event Number
- 68109
- Firm
- The Anspach Effort, Inc.
- FEI Number
- 1045834
- Product Code
- HTT
- Status
- Terminated
- Root Cause
- Labeling mix-ups
- Initiated
- January 8, 2014
- Posted
- May 9, 2014
- Terminated
- January 20, 2015
- Address
- 4500 Riverside Drive, Palm Beach Gardens, FL, 33410-4235
Description
ANSPACH Cutting bur, 3 mm Diamond Ball, Standard Length. REF L-3SD Use with LONG Attachments. Used for cutting and shaping bone, including the spine and cranium.
Anspach product code L-3SD contained product code S-3SD which is shorter in length than the labeled product.
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 [email protected].. 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.
Nationwide Distribution including FL, TX, NC, IL, CO, and PA.
30 cutting burs affected