RecallDepth

Biosure Ratchet Driver, Product No: 72201888 For delivery and placement of orthopedic screws. Arthroscopic surgical instrument

Company
Smith & Nephew, Inc., Endoscopy Div.
Recall Initiated
April 4, 2013
Posted
January 29, 2016
Terminated
March 22, 2021
Recall Number
Z-0700-2016
Quantity
9
Firm Location
Mansfield, MA

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

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.

Lot / Code Info

Lot Numbers: 50410950 and 50407175

Root Cause

Employee error

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.

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