Recalls / —

—#153149

Product

Smith & Nephew Dyonics Saw Blade, Short, Narrow, Product Number 3704

FDA product code

HAB — Saw, Powered, And Accessories

Device class

Class 1

Medical specialty

General, Plastic Surgery

Affected lot / code info

Batch Numbers: 50525150 50386077 50261802 50197616 50178740 50171398 50158656 50138050 50121538 50103379 50089298 50082582 50061131

Why it was recalled

The single use devices are provided sterile and do not have an expiration date on the label.

Root cause (FDA determination)

Labeling Change Control

Action the firm took

Smith & Nephew, Inc. initiated recall by letter on 2/2/17 advising of the problem, requesting inspection of inventory and return of product. Contact Smith & Nephews Field Actions Department via email at FieldActions@smith-nephew.com or fax +1-901-566-7975 to return.

Recalling firm

Firm

Smith & Nephew, Inc.

Address

1450 E Brooks Rd, Memphis, Tennessee 38116-1804

Distribution

Distribution pattern

Nationwide Foreign: Brazil, Canada, Chile , China, Denmark, Hong Kong, India, Mexico, Peru, Singapore, Venezuela

Timeline

Recall initiated

2017-02-02

Terminated

2019-09-20

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #153149. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.