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