Biosure Driver, Product No: 72201887 For delivery and placement of orthopedic screws. Orthopedic Manual Surgical Instrum

FDA device recall Z-0699-2016 · posted 2016-01-29 · Terminated

Recall details

Recalling firm

Smith & Nephew, Inc., Endoscopy Div.

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.

Action taken

Smith & Nephew sent an "Urgent-Product Recall 1st. Notification" dated April 3, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please inspect your inventory and locate all devices from the above listed product and lot numbers and quarantine them immediately. For further questions, please call (978) 749-1000.

Root cause

Employee error

Status

Terminated

Product code

HWR

Quantity affected

157

Distribution

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 B

Date initiated

2013-04-04

Date posted

2016-01-29

Date terminated

2021-03-22

Location

Mansfield, MA