Devices

Device Recall Formula 180 Shaver Hand Control

Model / Serial
Formula Shaver Hand Control, PN 375-704-500 and Formula 180 (PN 375-708-500). Serial numbers: 12B037204, 12B037214, 12B037224, 12B037234, 12B040594, 12B040604, 12B040614, 12B040624, 12B040634, 12B040644, 12B040654, 12B040664, 12B040684, 12B041374, 12B046934, 12B046964, 12B046974, 12B046994, 12B047004, 12B047014, 12B047024, 12B047034, 12B047054, 12B047064, 12B047074, 12B047084, 12B047094, 12B049204, 12B049234, 12B049244, 12B055744, 12B055754, 12B055764, 12B055774.
Product Classification
General and Plastic Surgery Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide distribution: USA (nationwide) including states of: CA, FL, IA , MI, NV, NC, OK, TX, and WI; and countries of: China and Great Britain.
Product Description
Formula Shaver Handpiece (with buttons); || Formula 180 Shaver Handpiece (with button) || Rx only, Made USA.: || Stryker Endoscopy || 5900 Optical Court || San Jose, CA 95138 || Components within the Crossfire System that provided abrasion, resection, debridement and removal of bone and soft tissue through the Formula Shaver and blade, and the ablation and coagulation of soft tissue, as well as hemostasis of blood vessels through its SERFAS Energy electrosurgical probe.
Manufacturer
Stryker Endoscopy
1 Event
- Recall of Device Recall Formula 180 Shaver Hand Control

Manufacturer

Stryker Endoscopy

Manufacturer Address
Stryker Endoscopy, 5900 Optical Ct, San Jose CA 95138-1400
Manufacturer Parent Company (2017)
Stryker
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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