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Recall Observatory FDA recall evidence

Device product

HARMONIC HD 1000i Shears (20cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Product Code: HARHD20

Z-2355-2021

July 20, 2021

Class II

Product summary

Firm
Ethicon Endo-Surgery Inc
Event
Event 88434
Status
Ongoing
Classification
Class II
Quantity
7870 units
Official record key
device-enforcement:Z-2355-2021

Official wording

Reason: An internal component may be cracked and become lodged behind the energy button potentially resulting in continuous activation of the device, may result in burns

Code information: Lot Codes: U95126 U9571N U9526Z U95A80 U9543P U95T0X U9550G GTIN: 10705036015048

Distribution pattern: Worldwide distribution - US Nationwide distribution and the countries of Austria, Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Mongolia, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United Arab Emirates.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    An internal component may be cracked and become lodged behind the energy button potentially resulting in continuous activation of the device, may result in burns