Reported Feb 4, 2015 · Terminated
Verasense Knee System, Model SYK-TRCR 02. Intelligent disposable tibial insert that measures dynamic loads during…
Orthosensor, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Orthosensor, Inc. · 1560 Sawgrass Corporate Pkwy · Sunrise, FL · 33323-2858
Is this the product you have?
- Verasense Knee System, Model SYK-TRCR 02. Intelligent disposable tibial insert that measures dynamic loads during orthopedic knee surgery.
- Lot codes and dates
Model SYK-TRCR 02Lot # 091914V11770Serial #s: 411654008411585023411654007411585032411585014411654016411585017411654015411585030411654020411654004411654010411585007411585005411654011411585036411585035411654018411654012411585011411654014411654005411654001411585003
- Amount recalled
- 22 devices
Where it was sold
Why it was recalled
Presence of one inoperable (dead) sensor pad.
This product could cause temporary or reversible health problems — stop using it.
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