—#128083

Product

Anspach Pneumatic and Electric Motor Systems. Intended for cutting and shaping bone, including the spine and cranium.

FDA product code: HSZ — Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
Device class: Class 1
Medical specialty: General, Plastic Surgery
510(k) numbers: K955084
Affected lot / code info: 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.

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

Customers 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.

Recalling firm

Firm: The Anspach Effort, Inc.
Address: 4500 Riverside Drive, Palm Beach Gardens, Florida 33410-4235

Distribution

Distribution pattern: Worldwide 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.

Timeline

Recall initiated: 2014-05-08
Posted by FDA: 2014-07-03
Terminated: 2016-01-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #128083. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.