Recall Z-2418-2015 ยท GAD Retractor
Synthes (USA) Products LLC
Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long; Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long are system specific instruments to the 3.5 mm Low Profile Pelvic System Retractor Set.
| Date | Aug 19, 2015 (initiated Jul 29, 2015) |
| Status | Terminated |
| Reason | Potential for micropores to form, allowing fluid to enter the hollow handle. |
| Root cause | Process control |
| Action | Urgent recall letters, dated July 29,2015, were sent to end users and sales consultants to inform them of the issue, potential risks, and to provide instructions for returning affected devices and the response form. |
| Quantity | 1113 |
| Distribution | Nationwide and internationally, including Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.