***REF MCA7-2SB***2 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: C523029789, D113032927, D333038386, D113032982, D093032541 and D243033308. Intended usage: Cutting and shaping bone including bones of the spine and cranium.
This recall has been terminated (originally issued April 20, 2011).
- Company
- The Anspach Effort, Inc.
- Recall Initiated
- September 29, 2010
- Posted
- April 20, 2011
- Terminated
- August 12, 2011
- Recall Number
- Z-2039-2011
- Quantity
- 271 cutting burs affected
- Firm Location
- Palm Beach Gardens, FL
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
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.
Lot / Code Info
Lot numbers: C523029789, D113032927, D333038386, D113032982, D093032541 and D243033308.
Root Cause
Other
Action Taken
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.