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Terminated

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

FDA Recall Z-1029-2015 · Posted 2015-01-29

Recalling FirmOrthosensor, Inc.
Recall StatusTerminated
Product CodeONN
Date Initiated2014-12-05
Date Terminated2015-03-13
Product Quantity22 devices

Reason for Recall

Presence of one inoperable (dead) sensor pad.

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.

Root Cause

Under Investigation by firm

Distribution Pattern

US Distribution to the states of : IL, MI, NY, CA, VA and NV.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K130380ORTHOSENSOR KNEE BALANCEROrthosensor, Inc. · 2013-06-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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