Recall Z-0656-2014 ยท ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
The Anspach Effort, Inc.
***REF MICROMAX***microMax Handpiece***Rx Only***Manufacturer: The Anspach Effort, Inc. Intended for cutting and shaping bone.
| Date | Jan 9, 2014 (initiated Apr 25, 2013) |
| Status | Terminated |
| Reason | 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.. |
| Root cause | Component design/selection |
| Action | The firm, Anspach sent an "URGENT" Medical Devics Removal" letter dated April 24, 2013, to its customers. Customer Immediate Actions: 1. Screen your current inventory and return all Anspach Pneumatic Drill System without a pressure Relief valve (PRV) from your inventory. 2. If you have any product listed on the attached form to arrange for immediate return and replacements. 3. complete the attached Customer Reply form indicating the product being returned. 4. Upon receipt of a replacement product, equipment being returned must be received by Anspach within 10 business days of the replacement r |
| Quantity | 1,224 |
| Distribution | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K965080 | ANSPACH MICROMAX SYSTEM The Anspach Effort, Inc., Jan 10, 1997 |