Recall Z-1758-2018 ยท GAD Retractor
Synthes (USA) Products LLC
Retractor f/Sciatic Nerve; Part number: 03.100.013; UDI: 10886982070623
| Date | Apr 2, 2018 |
| Status | Terminated |
| Reason | There is a potential for microspores to form on the hollow handle of the Sciatic Nerve Retractor. The pores may increase in size, allowing fluid to enter the hollow handle. |
| Root cause | Under Investigation by firm |
| Action | On April 2, 2018 Synthes (USA) LLC mailed an Urgent Product Recall notification letter to affected customers. Customers were instructed to: Review current inventory to identify and quarantine all affected products; Complete the Verification section of the Return Receipt form; Return affected product; Forward the notification to anyone in your facility that needs to be informed; If affected products have been forwarded to another facility, contact that facility to arrange return; Keep a copy of the notification. Customers with questions may call (610)719-5450 or contact your Depuy Synthese Sa |
| Quantity | 235 |
| Distribution | US Nationwide and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.