FDA Recalls 84 Zimmer CAS SmartTools Knee System Instruments
Orthosoft, Inc. dba Zimmer CAS is recalling 84 SmartTools Knee System Orthopedic Stereotaxic Instruments due to complaints of bent or broken Drive Pins.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (broken instrument components) where no injuries have been reported, meeting the criteria for a High severity score.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 84 units of the SmartTools Knee System Orthopedic Stereotaxic Instrument. The recall is being conducted by Orthosoft, Inc. dba Zimmer CAS. The affected products were distributed nationwide.
The recall was initiated due to an increase in complaints regarding bent or broken Drive Pins on the Validation Tool. These specific components were manufactured with drawing Revision M to P. The source text does not report any injuries or illnesses associated with this defect.
Healthcare providers and consumers should stop using the affected SmartTools Knee System Orthopedic Stereotaxic Instruments immediately. The following lot numbers are included in this recall: 130542A1, 1405941, 140146, 140146-1, 140147, 140407A, 140407A-1, 140407B, 140407-B-1, 140860, 140860-1, 141035, 150120, B150120, and B150711. Users should contact the manufacturer for instructions on returning the product.
The recalled product
- Product
- SmartTools Knee System Orthopedic Stereotaxic Instrument
- Manufacturer
- Orthosoft, Inc. dba Zimmer CAS
- Affected units
- 84
Distribution
Distributed nationwide across the United States.
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