Recall Z-1037-2015 ยท HBC Motor, Drill, Electric
The Anspach Effort, Inc.
16cm Minimally Invasive Attachment. For use with Motor Systems for cutting and shaping bones, including the spine and cranium. Model MIA16-G1
| Date | Feb 2, 2015 (initiated Dec 10, 2014) |
| Status | Terminated |
| Reason | Customer complaint indicating the color bands on the MIA16-G1 were not correct. |
| Root cause | Environmental control |
| Action | Anspach sent an "URGENT MEDICAL DEVICE RECALL" (Removal) letter dated December 10, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm requested the customer to 1) Immediately identify and set aside all product listed below 2) Review, complete, sign and return the attached reply form 3) Share this letter with others in your facility that need to be made aware of this recall 4) If you distribute any of the affected products to other services or facilities, please forward this letter as appropriate 5) Mainta |
| Quantity | 8 |
| Distribution | US Distribution to the states of: NC and CA., and Internationally to Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133604 | ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS The Anspach Effort, Inc., Jan 10, 2014 |