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U.S. Department of Health and Human Services

Class 2 Device Recall Anspach Pneumatic and Electric Motor Systems

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 Class 2 Device Recall Anspach Pneumatic and Electric Motor Systemssee related information
Date Initiated by FirmMay 08, 2014
Date PostedJuly 03, 2014
Recall Status1 Terminated 3 on January 29, 2016
Recall NumberZ-1983-2014
Recall Event ID 68496
510(K)NumberK955084 
Product Classification Instrument, surgical, orthopedic, pneumatic powered; accessory/attachment - Product Code HSZ
ProductAnspach Pneumatic and Electric Motor Systems. Intended for cutting and shaping bone, including the spine and cranium.
Code Information DFU:  18-0047: Revisions A & B  18-0074: Revision A; and  18-0105: Revisions A.  Operating Manuals:  19-0010: Revisions A, and  19-0013: Revisions A, B, & C.
Recalling Firm/
Manufacturer		 The Anspach Effort, Inc.
4500 Riverside Drive
Palm Beach Gardens FL 33410-4235
For Additional Information ContactSuzanne Goodman
561-627-1080
Manufacturer Reason
for Recall		Several attachments and handpieces failed to meet the expected sterility assurance level (SAL) when sterilized by the method that is specified in the current Directions for Use (DFU) provided with the device.
FDA Determined
Cause 2		Process control
ActionCustomers were notified 05/08/2014 by a Return Receipt Requested letter from Anspach with an URGENT: Medical Device Labeling Correction announcement, REGARDING: STERRAD 100S Hydrogen Peroxide Gas Plasma Technology no longer recommended for sterilization of Anspach products. The letter identified the problem and actions to be taken by the customer. Customers were to complete and return the attached reply form. If the products were distributed further, then those customers should have been notified as well. Customers were to contact Anspach Customer Support at 1-800-327-6887 if they want copies of the revised labeling.
Quantity in Commerce115,988 units
DistributionWorldwide Distribution -- USA, including the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX,UT, VA, VT, WA, WI, WV, WY, and Hawaii, and the territories of Puerto Rico, US Virgin Island and Guam; and, the countries of Argentina, Australia, Austria, Belgium, Brazil, Cameroon, Canada, Chile, Costa Rica, Czech Republic, Dominican Republic, Egypt, Finland, France, Germany, Grand Cayman, Hong Kong, India, Israel, Jamaica, Japan, Korea, Lithuania, Malaysia, Mexico, Nassau, Netherlands, Nigeria, Palestine, Panama, Poland, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Syria, Thailand, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = HSZ
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