***REF MCA7-1SB*** 1 mm Fluted Ball, 7.3 cm. Use with Micro Curved Attachment (MCA).***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only***Made in the USA***Manufacturer: The Anspach Effort, Inc. 4500 Riverside Drive, Palm Beach Gardens, FL 33410 USA Tel: (800) 327 6887/ +1 561 627 1080***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High Wycombe, HP11 1LA United Kingdom Tel: +441494 616126*** Lot numbers: C523029652, D063031867, D113032925, D173034373 and D213035424. Intended usage: Cutting and shaping bone including bones of the spine and cranium.
Recall
- Recall Number
- Z-2038-2011
- Event Number
- 57933
- Firm
- The Anspach Effort, Inc.
- FEI Number
- 1045834
- Product Code
- HTT
- Status
- Terminated
- Root Cause
- Other
- Initiated
- September 29, 2010
- Posted
- April 20, 2011
- Terminated
- August 12, 2011
- Address
- 4500 Riverside Drive, Palm Beach Gardens, FL, 33410-4235
Description
***REF MCA7-1SB*** 1 mm Fluted Ball, 7.3 cm. Use with Micro Curved Attachment (MCA).***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only***Made in the USA***Manufacturer: The Anspach Effort, Inc. 4500 Riverside Drive, Palm Beach Gardens, FL 33410 USA Tel: (800) 327 6887/ +1 561 627 1080***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High Wycombe, HP11 1LA United Kingdom Tel: +441494 616126*** Lot numbers: C523029652, D063031867, D113032925, D173034373 and D213035424. Intended usage: Cutting and shaping bone including bones of the spine and cranium.
Anspach Effort, Inc. Palm Beach Gardens, FL is recalling their Sterile Bone Cutting Burs that was manufactured with incomplete flutes which could cause degraded cutting performance and in some cases not cut at all. Anspach has not received any complaints related to this problem.
The firm, Anspach, sent an "URGENT: Medical Device Product Removal" letter dated October 6, 2010, to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to do the following: 1) Screen their inventory immediately for any of the part numbers listed in the letter. Do not include any product received after October 7, 2010. 2) If they have any of the products listed, contact Anspach Customer Support at (800) 327-6887 to arrange for their immediate return and replacement. 3) Complete and return the attached Customer Reply Form indicating how many of each part number is being returned and confirming their receipt of this letter, and fax to 1-800-327-6661. If they have distributed 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.
Worldwide distribution: USA including states of: AZ, CA, FL, GA, IL, IN, LA, MA, and MI; and countries of: Australia, Belgium, England, France, Italy, Japan, South Africa, Spain and Sweden.
271 cutting burs affected