Recall Z-0398-2018 ยท HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
The Anspach Effort, Inc.
OSCILLATING SAW ATTACHMENT Surgical instrument motors and accessories/attachments are intended for use during surgical procedures to cut hard tissue or bone and soft tissue.
| Date | Jan 11, 2018 (initiated Sep 29, 2017) |
| Status | Terminated |
| Reason | This voluntary recall was initiated because a veterinary unit was physically shipped in error to a non-veterinary customer account. |
| Root cause | Under Investigation by firm |
| Action | On November 15, 2017 the firm sent letter to their only consignee. Our records show that your facility has received the product subject to this removal. 1. Immediately review your inventory to identify and quarantine the affected product listed above in a manner that ensures the affected product will not be used. 2. Review, complete, sign and return the attached reply form on page 3 of this letter to your local DePuy Synthes sales organization in accordance with the directions on the form within 5 business days of receipt of this notification. 3. Return the affected product as soon as possib |
| Quantity | 1 |
| Distribution | Internationally to Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.