Recall Z-2038-2011 ยท HTT Burr, Orthopedic
The Anspach Effort, Inc.
***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 Unite
| Date | Apr 20, 2011 (initiated Sep 29, 2010) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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 h |
| Quantity | 271 cutting burs affected |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.