Tibial Alignment Guide; Orthopedic Stereotaxic Instrument;

FDA device recall Z-1701-2015 · posted 2015-06-02 · Terminated

Recall details

Recalling firm

Zimmer CAS

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.

Action taken

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 CorporateQuality.PostMarket@zimmer.com. 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 : cas-support@zimmercas.com, 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.

Root cause

Device Design

Status

Terminated

Product code

OLO

Quantity affected

78 devices

Distribution

Nationwide Distribution including AL, AZ, CA, CA, CO, FL, IN, MI, NJ, NY, OH, OR, PA, TX, VA, and WI.

Date initiated

2015-04-19

Date posted

2015-06-02

Date terminated

2016-05-13

Location

Montreal, Canada

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