Z-0699-2016 Class II Terminated
FDA device recall Z-0699-2016 was initiated by Smith & Nephew, Inc., Endoscopy Div. on April 4, 2013 and is designated Class II. Reason for recall: Driver does not meet specification, oversized. Driver may not be able to be fully inserted into the screw, or screw may become stuck on the driver. The recall status is terminated (terminated March 22, 2021). Affected quantity: 157.
Recall Details
- Product Type
- Devices
- Report Date
- February 10, 2016
- Initiation Date
- April 4, 2013
- Termination Date
- March 22, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 157
Product Description
Biosure Driver, Product No: 72201887 For delivery and placement of orthopedic screws. Orthopedic Manual Surgical Instrument
Reason for Recall
Driver does not meet specification, oversized. Driver may not be able to be fully inserted into the screw, or screw may become stuck on the driver.
Distribution Pattern
Worldwide Distribution - US Distribution to the states of : AK, AL, CA, CO, FL, IL, IN, MI, NE, NJ, NY, OH, OK, PA, SC, TN and TX., and to the countries of : Austria, Australia, Canada, Dubai, Great Britain, India, Italy, Korea, Malaysia, Netherlands, Portugal, Sweden, Switzerland, Singapore and South Africa.
Code Information
Lot Numbers: 50409038, 50404149, 50399964