FDA Medical Device Recalls (openFDA)
Zimmer CAS: Tibial Alignment Guide; Orthopedic Stereotaxic Instrument;
- Recall number
- Z-1701-2015
- Recalling firm
- Zimmer CAS
- Product
- Tibial Alignment Guide; Orthopedic Stereotaxic Instrument;
- Status
- Terminated
- Initiated
- 2015-04-19
- Posted
- 2015-06-02
- Terminated
- 2016-05-13
- 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.
- 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 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.
- Quantity
- 78 devices
- Distribution
- Nationwide Distribution including AL, AZ, CA, CA, CO, FL, IN, MI, NJ, NY, OH, OR, PA, TX, VA, and WI.
- Lot, serial or model codes
- Item Number: 20-8011-013-00; Lot Numbers: 120265; 110623; 120659; 120794;120659-1; 130134; 120793; 130135
- 510(k) numbers
- ["K122326"]
- PMA numbers
- not on file
- Product code
- OLO
- Firm FEI
- 3003714383
- Firm city
- Montreal
- Firm state
- not on file
- Firm country
- Canada
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28