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.
Recall
- Recall Number
- Z-0765-2017
- Event Number
- 75675
- Firm
- Stryker Sustainability Solutions
- FEI Number
- 3009350690
- Product Code
- NLM
- Status
- Terminated
- Root Cause
- No Marketing Application
- Initiated
- November 11, 2016
- Posted
- December 14, 2016
- Terminated
- May 5, 2017
- Address
- 1810 W Drake Dr, Tempe, AZ, 85283-4327
Description
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.
An increase in reports indicating that the reprocessed H12LP Trocar adjustable plug may break in the packaging or during use.
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 prepaid shipping label will be issued for the return of the product. Credit for all affected devices returned will be issued to your facility. Address any questions regarding the recall to Novasyte by calling (760) 279-3180 or emailing [email protected].
Worldwide Distribution - US (nationwide) and Internationally to Israel and Canada Foreign distribution to the following; IL and CA
40,476 devices