—#116740

Product

TRIGEN (TM) L-P SCREW, 4.5 MM X 37.5 MM, TI-6AL-4V, QTY: (1), STERILE R, REF 71645437, Smith & Nephew, Inc. Memphis, TN 38116 USA orthopedic surgery

FDA product code: HSB — Rod, Fixation, Intramedullary And Accessories
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K111025
Affected lot / code info: Lot Number 12FM12182

Why it was recalled

One batch of 4.5 mm diameter Trigen Low-Profile Bone Screws were incorrectly anodized with a gold coating (indicating a 5 mm diameter) instead of a gray coating (indicating a 4.5 mm diameter).

Root cause (FDA determination)

Process control

Action the firm took

Smith & Nephew sent an Urgent Product Recall Notification letter dated March 6, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to cease use and distribution of the affected product and quarantine for return. Non-responding consignees were notified again on March 15, 2013, by email. Surgeons were to be notified by letter beginning on March 20, 2013. For questions regarding this recall call 978-749-1330.

Recalling firm

Firm: Smith & Nephew Inc
Address: 1450 E. Brooks Rd, Memphis, Tennessee 38116

Distribution

Distribution pattern: Nationwide Distribution including CA, FL, GA, MA, MI, NC, SC, OH, and MO.

Timeline

Recall initiated: 2013-03-06
Posted by FDA: 2013-04-17
Terminated: 2019-08-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #116740. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.