FDA Enforcement Class II Terminated

Smith & Nephew Dyonics Saw Blade, Long, Special, Product Number 3706

Recall: Z-1244-2017 · Reported March 1, 2017

Enforcement

Recall Number
Z-1244-2017
Event ID
76414
Classification
Class II
Status
Terminated
Product Type
Devices
Firm
Smith & Nephew, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
Letter
Report Date
March 1, 2017
Initiation Date
February 2, 2017
Classification Date
February 22, 2017
Termination Date
September 20, 2019
Address
1450 E Brooks Rd, N/A, Memphis, TN, 38116-1804, United States

Description

Smith & Nephew Dyonics Saw Blade, Long, Special, Product Number 3706

Reason

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

Code Info

Batch Numbers: 50439354 50393992 50252777 50208023 50171402 50138054 50103142 50066114 576304

Distribution

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

Quantity

1410