Anspach Pneumatic and Electric Motor Systems. Intended for cutting and shaping bone, including the spine and cranium.
Reported: July 9, 2014 Initiated: May 8, 2014 #Z-1983-2014
Product Description
Anspach Pneumatic and Electric Motor Systems. Intended for cutting and shaping bone, including the spine and cranium.
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.
Details
- Recalling Firm
- The Anspach Effort, Inc.
- Units Affected
- 115,988 units
- Distribution
- 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.
- Location
- Palm Beach Gardens, FL
Frequently Asked Questions
What product was recalled? ▼
Anspach Pneumatic and Electric Motor Systems. Intended for cutting and shaping bone, including the spine and cranium.. Recalled by The Anspach Effort, Inc.. Units affected: 115,988 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 9, 2014. Severity: Moderate. Recall number: Z-1983-2014.
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