Fios First Entry; 5mm x 100mm and 12mm x 100mm; Model #:CTF03 and CTF73. Indicated for use to establish a port of entry

FDA device recall Z-1834-2015 · posted 2015-06-25 · Terminated

Recall details

Recalling firm

Stryker Sustainability Solutions

Reason for recall

Stryker Sustainability Solutions is recalling Trocars because they have received reports indicating that some may fracture at the distal tip resulting in fragments at the surgical site.

Action taken

On 06/01/15 a customer notification letter was sent out by the firm. The notification letter instructs customers to stop using the affected lots of the recalled product, and should consider other trocar models reprocesses by Stryker as an alternative. The letter notes that attached is a Effectiveness Check Form and complete list of affected lots shipped to the facility. A Stryker Sustainability Solutions Sales Representative will be sent to check the inventory of the affected lots. Once the inventory is checked the affected lots will be removed. The firm will complete a Recall Effectiveness Check Form . The form is to be completed even if no affected product is found. The firm requests that the form be returned to the sales representative or fax to 480-809-4975. 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 a credit for all affected devices returned. The firm states that adverse reactions or quality problems experiences with the use of the product may be reported to the firm's hotline 888-888-3433 x5572, or at www.stryker.com/productexperience as well as through FDA's MedWatch Adverse Event Reporting program.

Root cause

Under Investigation by firm

Status

Terminated

Product code

NLM

Quantity affected

147,351

Distribution

Distributed Nationwide including Puerto Rico.

Date initiated

2015-06-01

Date posted

2015-06-25

Date terminated

2016-08-16

Location

Tempe, AZ

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