Reported Dec 11, 2013 · Terminated
TB-0545PC: THUNDERBEAT 5 mm , 45 em, Pistol Grip TB-0535PC: THUNDERBEAT 5 mm, 35 em, Pi stol Grip TB-0545IC:…
Olympus America 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: Olympus America Inc. · 3500 Corporate Pkwy. · Center Valley, PA · 18034-0610
Is this the product you have?
- TB-0545PC
THUNDERBEAT 5 mm45 em
- Pistol Grip TB-0535PC
THUNDERBEAT 5 mm35 em
- Pi stol Grip TB-0545IC
THUNDERBEAT 5 mm45 em
- In line Grip TB-0535IC
THUNDERBEAT 5 mm35 em
- Inline Grip TB-0520IC
THUNDERBEAT 5 mm20 em
- In line Grip TB-051 OIC
THUNDERBEAT 5 mmI 0 em
- In line Grip TB-545FC
THUNDERBEAT 5 mm45 em
- Front Actuated Grip TB-0535FCTHUNDERBEAT 5 mm, 35 em, Front Actuated Grip The Olympus Thunderbeat Surgical Tissue Management System ("Thunderbeat") is intended to be used for open, laparoscopic (including single-site surgery), and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels
- Lot codes and dates
- All sold units
- Amount recalled
- 8709
Where it was sold
- Nationwide
- PR
Why it was recalled
Complaints of damage to various models of Thunderbeat Hand Instruments during surgical procedures, including cracking, breaking, or deformation of the components of the probe tip or jaw.
This product could cause temporary or reversible health problems — stop using it.
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