Recall Z-0765-2017 ยท NLM Laparoscope, General & Plastic Surgery, Reprocessed
Stryker Sustainability Solutions
Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures.
| Date | Dec 14, 2016 (initiated Nov 11, 2016) |
| Status | Terminated |
| Reason | An increase in reports indicating that the reprocessed H12LP Trocar adjustable plug may break in the packaging or during use. |
| Root cause | No Marketing Application |
| Action | Stryker sent an Urgent Medical Device Recall letter to all affected customers on November 11, 2016. Customers were instructed to discontinue use of the affected lots and were asked to follow the link below to complete the Recall Effectiveness Check Form and indicate if any devices from the lots referenced in Attachment 1 remain in their inventory. This form must be completed even if no affected product is found. www.novasyte.com/sss142 Use the following reference number as you complete the form: [Ship to Account #]. If the form indicates that any affected devices remain in your inventory, a |
| Quantity | 40,476 devices |
| Distribution | Worldwide Distribution - US (nationwide) and Internationally to Israel and Canada Foreign distribution to the following; IL and CA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062497 | REPROCESSED TROCARS Ascent Healthcare Solutions, Jan 31, 2007 |