Stryker Sustainability Solutions CB5LT Ethicon Endo-Surgery, Inc. Excel Trocar Sleeve w/Stability Sleeve 5mm x 100mm Rep

FDA device recall Z-2468-2015 · posted 2015-08-27 · Terminated

Recall details

Recalling firm

Stryker Sustainability Solutions

Reason for recall

Stryker Sustainability Solutions has received reports indicating that devices from one lot (lot# 3574704) were labeled as 100mm models (CB5LT) while the devices inside of the packaging were 75mm models (CB5ST).

Action taken

On 07/10/15 the firm sent out notification letters to all customers. The letter states for the customer to discontinue use of the affected lot, and to use other trocar lots reporcessed by the firm. The firm requests that the Recall Effectiveness Check Form be completed. The firm is going to be sending a sales representative to the facilities to check inventory for the affected trocars. A Recall Effectiveness Check will also be completed. If the form indicates that affected devices remain in inventory a prepaid shipping label will be issued for the return of the product. Customers will receive credit for all affected devices returned. The form must be completed even if no affected devices are found in inventory. Stryker Sustainability Solutions Complaint Hotline: 1-888-888-3433 x5555

Root cause

Labeling mix-ups

Status

Terminated

Product code

NLM

Quantity affected

90 devices

Distribution

U.S. Nationwide Distribution to the following states of:: NV, NM, TX, and MI.

Date initiated

2015-07-10

Date posted

2015-08-27

Date terminated

2015-12-04

Location

Tempe, AZ

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