FDAClass IIFebruary 10, 2016

Biosure Ratchet Driver recall

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

Why was Biosure Ratchet Driver recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Numbers: 50410950 and 50407175

Product
Biosure Ratchet Driver, Product No: 72201888 For delivery and placement of orthopedic screws. Arthroscopic surgical instrument
Recalling firm
Smith & Nephew, Inc., Endoscopy Div.
Quantity
9
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.
Recall date
February 10, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls