Recall Z-1243-2017

Smith & Nephew, Inc. · initiated February 2, 2017

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

Smith & Nephew Dyonics Saw Blade, Narrow, Product Number 3705

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

Reason for recall

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

FDA-determined cause: Labeling Change Control

Action taken

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.

Details

Recall number
Z-1243-2017
Initiated
February 2, 2017
Terminated
September 20, 2019
Product code
HAB – Saw, Powered, And Accessories
Quantity
3462
Distribution
Nationwide Foreign: Brazil, Canada, Chile , China, Denmark, Hong Kong, India, Mexico, Peru, Singapore, Venezuela
Recalling firm
Smith & Nephew, Inc., Memphis, TN

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-1239-2017 Class IISmith & Nephew Dyonics Saw Blade, Standard, Product Number 3701The single use devices are provided sterile and do not have an expiration date on the label. 02/02/2017Terminated
Z-1240-2017 Class IISmith & Nephew Dyonics Saw Blade, Standard, Thick, Product Number 3702The single use devices are provided sterile and do not have an expiration date on the label. 02/02/2017Terminated
Z-1241-2017 Class IISmith & Nephew Dyonics Saw Blade, Short, Product Number 3703The single use devices are provided sterile and do not have an expiration date on the label. 02/02/2017Terminated
Z-1242-2017 Class IISmith & Nephew Dyonics Saw Blade, Short, Narrow, Product Number 3704The single use devices are provided sterile and do not have an expiration date on the label. 02/02/2017Terminated
Z-1244-2017 Class IISmith & Nephew Dyonics Saw Blade, Long, Special, Product Number 3706The single use devices are provided sterile and do not have an expiration date on the label. 02/02/2017Terminated