Z-1029-2015Class II

Verasense Knee System, Model SYK-TRCR 02. Intelligent disposable tibial insert that measures dynamic loads...

Name: Z-1029-2015 Verasense Knee System, Model SYK-TRCR 02. Intelligent disposable tibial insert that measures dynamic loads...
Creator: Orthosensor, Inc.
Published: 2014-12-05
License: https://open.fda.gov/license/

Orthosensor, Inc. / initiated 2014-12-05 / Terminated

FDA source

Orthosensor, Inc. began a recall of Verasense Knee System, Model SYK-TRCR 02. Intelligent disposable tibial insert that measures dynamic loads during orthopedic knee surgery on 2014-12-05. FDA classified it as Class II and gives the reason as "Presence of one inoperable (dead) sensor pad". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1029-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-05
Posted: 2015-01-29
Terminated: 2015-03-13
Recalling firm: Orthosensor, Inc.
Product: Verasense Knee System, Model SYK-TRCR 02. Intelligent disposable tibial insert that measures dynamic loads during orthopedic knee surgery.
Product code: ONN Intraoperative Orthopedic Joint Assessment Aid
Reason for recall: Presence of one inoperable (dead) sensor pad.
FDA root cause: Under Investigation by firm
Action: OrthoSensor sent an Recall letter dated December 4, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Required Action for Users " Remove the above-referenced serial numbers from your VERASENSE inventory and quarantine. " Complete the enclosed Customer Response Form. Actions to be taken by OrthoSensor " You will be credited for these devices for your full purchase amount. The Returned Materials Authorization (RMA) number for each device in your possession is listed above. " OrthoSensor will replenish these devices as soon as they are available. For further questions please call (954) 577-7770.
Quantity in commerce: 22 devices
Distribution: US Distribution to the states of : IL, MI, NY, CA, VA and NV.
Product codes and lots: Model SYK-TRCR 02, Lot # 091914V11770, Serial #s: 411654008, 411585023, 411654007, 411585032, 411585014, 411654016, 411585017, 411654015, 411585030, 411654020, 411654004, 411654010, 411585007, 411585005, 411654011, 411585036, 411585035, 411654018, 411654012, 411585011, 411654014, 411654005, 411654001, 411585003.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1029-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1029-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-04	2015-01-29

Product code ONN

K130380Class IIOrthosensor Knee BalancerOrthosensor, Inc. / cleared 2013-06-13

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)