Recalls / —

—#147612

Product

Smith and Nephew TWINFIX QUICK-T Knot Pusher Suture Cutter; Part Number: 7209417, for arthroscopic use.

FDA product code

NBH — Accessories, Arthroscopic

Device class

Class 1

Medical specialty

Orthopedic

Affected lot / code info

Batch numbers: 50412843, 50477278, 50527184

Why it was recalled

The device could be subject to breaches of its sterile packaging.

Root cause (FDA determination)

Package design/selection

Action the firm took

Urgent Recall Notification Letters were sent via Federal Express on June 15, 2016, to the customers listed in the firm's distribution report. Customers were asked to inventory their devices and contact the firm for return authorizations.

Recalling firm

Firm

Smith & Nephew, Inc.

Address

130 & 120 Forbes Blvd, Mansfield, Massachusetts 02048

Distribution

Distribution pattern

Worldwide distribution. US nationwide, AT, AU, DE, FR, GB, JP, PT, and RU.

Timeline

Recall initiated

2016-06-15

Terminated

2021-03-22

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #147612. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.