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Recall Observatory FDA recall evidence

Device product

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

Z-0700-2016

April 04, 2013

Class II

Product summary

Firm
Smith & Nephew, Inc., Endoscopy Div.
Event
Event 72908
Status
Terminated
Classification
Class II
Quantity
9
Official record key
device-enforcement:Z-0700-2016

Official wording

Reason: 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.

Code information: Lot Numbers: 50410950 and 50407175

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.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    does not meet specification