Recalls / —

—#137084

Product

ULTRA-FAST FIX Knot Pusher Suture Cutters Product Number: 72201537 Intended for Meniscal Repair.

FDA product code

GAT — Suture, Nonabsorbable, Synthetic, Polyethylene

Device class

Class 2

Medical specialty

General, Plastic Surgery

510(k) numbers

K132079

Affected lot / code info

All batches manufactured from April 2010 to April 2014 which have corresponding expiration dates of April 2015 to April 2019

Why it was recalled

Sterility of device maybe compromised

Root cause (FDA determination)

Package design/selection

Action the firm took

Smith & Nephew sent an Urgent - Product Recall 1st Notification letter dated April 27, 2015, via Federal Express on April 30, 2015. Users are requested to inspect inventory and locate any unused devices from the above listed product and batch numbers, and quarantine them immediately. Complete the the Inventory Return Certification and obtain a RGA and obtain replacement product. Contact Smith & Nephews Field Action Department via email at FieldActions@smith-nephew.com or fax +1-901-566-7975 to obtain a return authorization (RA) number

Recalling firm

Firm

Smith & Nephew, Inc.

Address

150 Minuteman Rd, Andover, Massachusetts 01810-1031

Distribution

Distribution pattern

Worldwide Distribution - US (nationwide) Distribution including Puerto Rico and to the countries of : Argentina, Austria, Australia, Belgium, Brazil, Canada, Switzerland, Chile, China, Colombia, Costa Rica, Dubia UAE, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Guam, Hong Kong, Israel, India, Italy, Japan, Korea, Mexico, Malaysia, Netherlands, Norway, Portugal, Qatar, Sweden, Singapore,Thailand, Turkey, Taiwan, Venezuela and South Africa.

Timeline

Recall initiated

2015-04-30

Posted by FDA

2015-06-22

Terminated

2017-09-19

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #137084. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.