FDAClass IIApril 26, 2017

SmartTools Knee System Orthopedic Stereotaxic recall

SmartTools Knee System Orthopedic Stereotaxic Instrument

Why was SmartTools Knee System Orthopedic Stereotaxic recalled?

There has been an increase in the number of complaints regarding bent or broken Drive Pins of the Validation Tool manufactured with drawing Revision M to P

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?

Lots: 130542A1 1405941 140146 140146-1 140147 140407A 140407A-1 140407B 140407-B-1 140860 140860-1 141035 150120 B150120 B150711

Product
SmartTools Knee System Orthopedic Stereotaxic Instrument
Recalling firm
Orthosoft, Inc. dba Zimmer CAS
Quantity
84
Distribution
Nationwide Distribution
Recall date
April 26, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls