Z-1701-2015Class II

Tibial Alignment Guide; Orthopedic Stereotaxic Instrument

Name: Z-1701-2015 Tibial Alignment Guide; Orthopedic Stereotaxic Instrument
Creator: Zimmer CAS
Published: 2015-04-19
License: https://open.fda.gov/license/

Zimmer CAS / initiated 2015-04-19 / Terminated / root cause: design

FDA source

Zimmer CAS began a recall of Tibial Alignment Guide; Orthopedic Stereotaxic Instrument on 2015-04-19. FDA classified it as Class II and gives the reason as "Zimmer CAS has determined that the potential exists for the spikes on the iASSIST Tibial Alignment Guide to bend or break during insertion or extraction from the tibia during use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1701-2015
Classification: Class II
Status: Terminated
Initiated: 2015-04-19
Posted: 2015-06-02
Terminated: 2016-05-13
Recalling firm: Zimmer CAS
Product: Tibial Alignment Guide; Orthopedic Stereotaxic Instrument;
Product code: OLO Orthopedic Stereotaxic Instrument
Reason for recall: Zimmer CAS has determined that the potential exists for the spikes on the iASSIST Tibial Alignment Guide to bend or break during insertion or extraction from the tibia during use.
Root cause tag: design
FDA root cause: Device Design
Action: Zimmer distributed notices via certified mail on May 14, 2015. Zimmer is removing affected Tibial Alignment Guide iAssist Knee System product from distribution in a two-phased process. Based upon complaint investigation, Zimmer CAS has determined that the potential exists for the spikes on the iASSIST Tibial Alignment Guide to bend or break during insertion or extraction from the tibia during use. Customerswere asked to review the notifictaion, follow the iASSIST Surgical Knee Technique provided, further distribute the notice for any distributed product, inspect devices in use before and after procedures, report any adverse events, and complete the certificate of acknowledgment and return it to [email protected]. Customers with questions concerning this notice, please contact Customer Service at the following address/phone number. Customer Service / Zimmer CAS 75 Queen Street, Suite 3300 Montreal, Quebec, Canada H3C 2N6 Email : [email protected], Telephone : 1-514-395-8883, toll free for North America 1-866-336-7846, Fax : 1-866-978-3801. For questions regarding this recall 574-372-4487.
Quantity in commerce: 78 devices
Distribution: Nationwide Distribution including AL, AZ, CA, CA, CO, FL, IN, MI, NJ, NY, OH, OR, PA, TX, VA, and WI.
Product codes and lots: Item Number: 20-8011-013-00; Lot Numbers: 120265; 110623; 120659; 120794;120659-1; 130134; 120793; 130135

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1701-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1701-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-10	2015-06-02

Product code OLO

K122326Class IISmarttools Knee SystemZimmer / cleared 2012-11-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)