Recall Z-0198-2014 ยท HBC Motor, Drill, Electric
The Anspach Effort, Inc.
Pneumatic Systems Operating Manual (part numbers 19-0005) utilized with the Pneumatic Motor Systems including: BlackMax Motor Systems, MicroMax Systems and XMax Motor Systems all models and serial numbers. Product Usage: Indication for use is cutting and shaping bone.
| Date | Nov 13, 2013 (initiated May 6, 2011) |
| Status | Terminated |
| Reason | Anspach Effort, Inc. Palm Beach Gardens, FL initiated a correction of its medical Device labeling for its Pneumatic Systems Operating Manual, Cutting Burr Chart and Product Catalog due to a recent review of their regulations and compliance requirements that determined the claim that the device is capable of dissection of biometals, bioplastics and cement has been verified, but is is not part of th |
| Root cause | Labeling Change Control |
| Action | The firm, Anspach Effort, Inc., sent an "Urgent Medical Device Labeling Correction" letter dated June 27, 2011 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to do the following: 1) Destroy or delete any items in their inventory immediately and replace with the attached revised Operating Manual, Product Catalog and/or Cutting Bur Chart. 2) Complete and return the attached Customer Reply Form indicating disposition of the labeling materials and confirming their receipt of this letter, and fax to 1-800-327-6661. 3) If they dist |
| Quantity | 2,020 |
| Distribution | Worldwide Distribution: USA Nationwide and the countries of: Egypt, India, Germany, Turkey, Canada, Saudi Arabia, Greece, United Kingdom, Cayman Islands, Kazakhstan, Republic of Korea, Taiwan, Hong Kong, China, Lebanon, Argentina, Denmark, Belgium, Netherlands, Mexico, France, Australia, Panama, Ita |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011444 | ANSPACH EMAX DRILL SYSTEM The Anspach Effort, Inc., Aug 8, 2001 |