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Terminated

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

FDA Recall Z-0699-2016 · Posted 2016-01-29

Recalling FirmSmith & Nephew, Inc., Endoscopy Div.
Recall StatusTerminated
Product CodeHWR
Date Initiated2013-04-04
Date Terminated2021-03-22
Product Quantity157

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.

Firm Action

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

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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