Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopic Trocars are indicated for use to establis

FDA device recall Z-0765-2017 · posted 2016-12-14 · Terminated

Recall details

Recalling firm

Stryker Sustainability Solutions

Reason for recall

An increase in reports indicating that the reprocessed H12LP Trocar adjustable plug may break in the packaging or during use.

Action taken

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 sss142@novasyte.com.

Root cause

No Marketing Application

Status

Terminated

Product code

NLM

Quantity affected

40,476 devices

Distribution

Worldwide Distribution - US (nationwide) and Internationally to Israel and Canada Foreign distribution to the following; IL and CA

Date initiated

2016-11-11

Date posted

2016-12-14

Date terminated

2017-05-05

Location

Tempe, AZ

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