{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "120537", "product_res_number": "Z-0200-2014", "event_date_initiated": "2011-05-06", "event_date_posted": "2013-11-13", "recall_status": "Terminated", "event_date_terminated": "2016-01-28", "res_event_number": "65863", "product_code": "HBE", "k_numbers": [ "K080802" ], "product_description": "Product Catalog (part number 20-0020) utilized with the Electric and Pneumatic Motor Systems including: MicroMax Motor Systems, XMax Motor Systems, EMax2 Motor Systems, and Emax2Plus Motor Systems, all models and serial numbers.\n\nProduct Usage: Indication for use is cutting and shaping bone.", "code_info": "part number 20-0020", "firm_fei_number": "1045834", "recalling_firm": "The Anspach Effort, Inc.", "address_1": "4500 Riverside Drive", "city": "Palm Beach Gardens", "state": "FL", "postal_code": "33410-4235", "additional_info_contact": "Denise DeLuigi\n561-494-3711", "reason_for_recall": "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_description": "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 distributed any of the products to other services or facilities, please forward this information as appropriate. For additional copies, contact Anspach Customer Support at (800) 327-6887.", "product_quantity": "2,020", "distribution_pattern": "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, Italy, Guam, United Arab Emirates, Israel, Polan, Venezuela, Austria, Hungary, Lithuania, Norway, Malaysia, Colombia, Costa Rica, Ecuador, Jamaica, Peru, Thailand, Italy, Czech Republic, Cameroon, South Africa, Portugal, Finland, Sweden, Nigeria, Bahamas, Cambodia, Dominican Republic, Switzerland, Chile, Singapore, Spain, Syrian Arab Republic, Jordan, Japan.", "openfda": { "k_number": [ "K984035", "K903664", "K162542", "K202120", "K080802", "K252060", "K172709", "K130755", "K223199", "K253627", "K905097", "K002903", "K190172", "K111520", "K121264", "K042783", 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