FDAFDA · Food and drugs·Recall number Z-0654-2014
***REF BLACKMAX-N***Swivel/Angle Motor Assembly***Rx Only***The Anspach Effort, Inc. Intended for cutting and shaping bone.
Published January 15, 2014 · Recall initiated: April 25, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The firm Anspach Effort of Palm Beach Gardens, FL initiated a voluntary removal of the Pneumatic Drill System, including the motor hand-piece, Auto Lube foot control, without a pressure relief valve (PRV) due to the hand piece's outer hose can rupture without warning if the air flow is blocked during use..
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- The Anspach Effort, Inc.
- Distributor
- Worldwide Distribution: US (nationwide) including Puerto Rico and states of: AL, AR, AZ, CA, CO, CT, DC, DE, GA, FL, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, VE, VT, WA, WI, WY, and WV. Internationally to: AT, AU, BR, BS, CA, CH, CL, CO, CZ, CR, DE, DK, DO, EG, ES, FI, FR, GB, GR, HK, HU, ID, IL, IN, IS, JP, KH, KR, LB, LT, MX, MY, NL, NO, NZ, PA, PE, PH, PL, PT, SA, SG, SY, TH, TR, TW, and ZA.
- Lot
- Serial Number 31496602
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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