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U.S. Department of Health and Human Services

Class 2 Device Recall Smith&Nephew Biosure

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 Class 2 Device Recall Smith&Nephew Biosuresee related information
Date Initiated by FirmApril 04, 2013
Date PostedJanuary 29, 2016
Recall Status1 Terminated 3 on March 22, 2021
Recall NumberZ-0699-2016
Recall Event ID 72908
Product Classification Driver, prosthesis - Product Code HWR
ProductBiosure Driver, Product No: 72201887 For delivery and placement of orthopedic screws. Orthopedic Manual Surgical Instrument
Code Information Lot Numbers: 50409038, 50404149, 50399964
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc., Endoscopy Div.
130 Forbes Blvd
Mansfield MA 02048
For Additional Information Contact
978-749-1000
Manufacturer 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.
FDA Determined
Cause 2		Employee error
ActionSmith & 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.
Quantity in Commerce157
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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