Verasense Knee System, Model SYK-TRCR 02. Intelligent disposable tibial insert that measures dynamic loads during orthop
FDA device recall Z-1029-2015 · posted 2015-01-29 · Terminated
Recall details
- Recalling firm
- Orthosensor, Inc.
- Reason for recall
- Presence of one inoperable (dead) sensor pad.
- Action taken
- 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
- Status
- Terminated
- Product code
- ONN
- Quantity affected
- 22 devices
- Distribution
- US Distribution to the states of : IL, MI, NY, CA, VA and NV.
- Date initiated
- 2014-12-05
- Date posted
- 2015-01-29
- Date terminated
- 2015-03-13
- Location
- Sunrise, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ORTHOSENSOR KNEE BALANCER (K130380) | Orthosensor, Inc. | 2013-06-13 |