Recalls / —

—#128230

Product

SUTUREFIX Ultra S Double Loaded Suture Product Code: 72203854 Fastener, fixation, nondegradable, soft tissue

FDA product code

MBI — Fastener, Fixation, Nondegradable, Soft Tissue

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K122059

Affected lot / code info

Lot Numbers: 50478984,50485736, 50485737, 50485738, 50487831, 50491901, 50493684

Why it was recalled

Sterility of device is compromised due to breach in sterile barrier

Root cause (FDA determination)

Package design/selection

Action the firm took

Smith & Nephew issued an Urgent - Product Recall Notification letter dated June 2, 2014 via Federal Express to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect their inventory and locate all affected product and quarantine them immediately. Complete the Return Certification Form . Contact the Smith & Nephew Returns Group at 800-343-5717 (option 3) or send an email to ProductRecoverv@smith-nephew.com. They will provide customers with instructions for returning their product and receiving a replacement. For questions regardin g this recall call 978-749-1073.

Recalling firm

Firm

Smith & Nephew, Inc. Endoscopy Division

Address

150 Minuteman Drive, Andover, Massachusetts 01810-1031

Distribution

Distribution pattern

Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Denmark, France, Germany, Great Britain, Italy, Netherlands, Norway, Portugal, Spain, and Sweden.

Timeline

Recall initiated

2014-06-02

Posted by FDA

2014-07-14

Terminated

2017-09-15

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #128230. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.