Recall Z-1868-2017— Orthosoft, Inc. dba Zimmer CAS

Name: FDA recall Z-1868-2017
Creator: U.S. Food and Drug Administration
Published: 2017-02-20

Class II · Terminated

Class II FDA medical device recall by Orthosoft, Inc. dba Zimmer CAS, initiated 2017-02-20, terminated 2017-09-18. It names one FDA 510(k) clearance: K122326. Product: SmartTools Knee System Orthopedic Stereotaxic Instrument. Reason: 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.

Recalling firm: Orthosoft, Inc. dba Zimmer CAS
Classification: Class II
Status: Terminated
Initiated: 2017-02-20
Terminated: 2017-09-18
Firm location: Montreal, N/A, Canada

510(k) clearances named in this recall

1 on FDA's record

K122326 — SMARTTOOLS KNEE SYSTEMZimmer·cleared 2012-11-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

SmartTools Knee System Orthopedic Stereotaxic Instrument

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.