Recall Z-0779-2014 ยท ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
The Anspach Effort, Inc.
Anspach MIA 16 (16cm Minimally Invasive Attachment), Rx Only MIA16 attachments are intended for use with Motor Systems for cutting and shaping bones, including the spine and cranium.
| Date | Jan 16, 2014 (initiated May 6, 2013) |
| Status | Terminated |
| Reason | Product did not reach expected sterility assurance level |
| Root cause | Unknown/Undetermined by firm |
| Action | The firm, Aspach, sent an "URGENT: MEDICAL DEVICE LABELING CORRECTION" letter dated May 13, 2013 to its consignees/customers. The letter described the product, problem and actions to be taken. The consignees/ customers were instructed that Sterrad 100S system should not be used on the MIA 16 attachment (the information only applies to only Sterrad sterilization of this devices and not to any other attachments.), and complete and return the Return Receipt Requested Customer Reply form via fax to: 1-800-327-6661 or email: ProductSupportTeam@synthes.com. If you distribute any of the products t |
| Quantity | 183 |
| Distribution | Nationwide Distribution: FL, IL, CA. IN, MI, CA, NJ, TX, NE, NC, OR, PA, TN, DC, UT, CO, MO, KY, MD, WV, NY, and MN. |
| FDA record | Open on fda.gov |