Recall Z-1701-2015— Zimmer CAS

Name: FDA recall Z-1701-2015
Creator: U.S. Food and Drug Administration
Published: 2015-04-19

Class II · Terminated

Class II FDA medical device recall by Zimmer CAS, initiated 2015-04-19, terminated 2016-05-13. It names one FDA 510(k) clearance: K122326. Product: Tibial Alignment Guide; Orthopedic Stereotaxic Instrument;. Reason: 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..

Recalling firm: Zimmer CAS
Classification: Class II
Status: Terminated
Initiated: 2015-04-19
Terminated: 2016-05-13
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

Tibial Alignment Guide; 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.

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