FDA Medical Device Recalls (openFDA)
Orthosensor, Inc.: Verasense Knee System, Model SYK-TRCR 02. Intelligent disposable tibial insert that measures dynamic loads during orthopedic knee surgery.
- Recall number
- Z-1029-2015
- Recalling firm
- Orthosensor, Inc.
- Product
- Verasense Knee System, Model SYK-TRCR 02. Intelligent disposable tibial insert that measures dynamic loads during orthopedic knee surgery.
- Status
- Terminated
- Initiated
- 2014-12-05
- Posted
- 2015-01-29
- Terminated
- 2015-03-13
- Reason
- Presence of one inoperable (dead) sensor pad.
- 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
- 22 devices
- Distribution
- US Distribution to the states of : IL, MI, NY, CA, VA and NV.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- K130380
- PMA numbers
- not on file
- Product code
- ONN
- Firm FEI
- 3008592715
- Firm city
- Sunrise
- Firm state
- FL
- Firm country
- not on file
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