Recall Z-2031-2017 ยท BWN Table And Attachments, Operating-Room
The Anspach Effort, Inc.
Sagittal MICRO-SAW
| Date | Oct 6, 2016 |
| Status | Terminated |
| Reason | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| Root cause | Under Investigation by firm |
| Action | Consignees were sent a recall notice via mail, dated 10/10/2016. In the notice, the firm notifies consignees of the Directions For Use (DFU) correction that will include recommended servicing intervals. All DFUs distributed after 09/28/2016 will have the correct DFU. The recalling firm instructs consignees to review the service intervals provided for product received, forward the notification to necessary parties and/or facilities, and complete the attached Verification Form. Complete Verification Forms are to be sent by fax to 877-546-5069 or by email to Anspach4870@stericycle.com. Consignees |
| Quantity | 62 |
| Distribution | Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080802 | EMAX 2 PLUS SYSTEM, MODEL EMAX 2 PLUS MOTOR, EMAX 2 CONSOLE>FIRMWARE UPGRADE, EMAX 2 FP FOOT PEDAL The Anspach Effort, Inc., Apr 30, 2008 |