HARMONICHD 1000i Shears (36cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Product Code: HARHD36
Check against the official notice below — it lists the full affected range.
Ethicon Endo-Surgery Inc. is recalling 68,960 units of the HARMONICHD 1000i Shears (36cm Shaft Length) due to a defect where an internal component may crack and become lodged behind the energy button. This defect can cause the device to continuously activate, potentially resulting in burns to users. The affected shears are surgical instruments intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. The recalled units were distributed worldwide, including throughout the United States and numerous countries in Europe, Asia, South America, and other regions.
The recall affects specific lot codes listed in the record, which consumers can use to identify whether their device is affected. The source document does not specify a remedy or recommended course of action for consumers who possess affected units.
Written by software from the official notice below. Not reviewed by a lawyer.
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
Reason for recall: 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 Distribution: 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, Polan Quantity: 68960 units Lot/code info: Lot Codes: U94Y9V U95C2A U94Z98 U95427 U9516E U95599 U9503G U95856 U94Y9W U95L0A U9518D U95526 U9507E U9548R U95127 U95525 U9530P U95T2Z U95366 U95R4F U9521Z U95F2T U9554U U95F8W U9564G U95U6A U95524 U95E6F U9512D U95K4D U94Z49 U95F07 U95A9X U95F6N U9569W U95E1U U9571P U95E72 U9587D U95E29 U95815 U95T90 U95814 U95Z67 U95754 U95Y7G U95D4T U9523L U95566 U9530X U9543R GTIN: 10705036015055
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.