RecallRadar

FDA Device recall Z-1029-2015

Verasense Knee System, Model SYK-TRCR 02

On 2015-02-04 the FDA classified a Class II recall of Verasense Knee System, Model SYK-TRCR 02 by Orthosensor, citing presence of one inoperable (dead) sensor pad.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1029-2015
ClassificationClass II
Statusterminated
Initiated2014-12-05
Published2015-02-04
Last updated2026-09-13 11:53 UTC
CompanyOrthosensor
DistributionCA, IL, MI, NV, NY, VA

Product

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

Reason

Presence of one inoperable (dead) sensor pad.

Identifiers

code_info
Model SYK-TRCR 02, Lot # 091914V11770, Serial #s: 411654008, 411585023, 411654007, 411585032, 411585014, 411654016, 411…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.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1029-2015%22

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