Device Recall HARMONIC Blue Hand Piece & HARMONIC Hand Piece

HARMONIC¿ HP054 Hand Pieces Lot Numbers produced to-date: H92Y3M, J9039C, J90817, J90E7C, J9000C, J90432, J9084W, J90E7Z, J90029, J90470, J9088L, J90F3G,J9006C, J9054E, J9093L, J90F7Z, J9011D, J9056K, J9095C, J90G32, J90151, J9057V,J90974, J90G9Y,J9018H, J9058L, J90A45, J90H37,J9020F, J90624, J90A72, J90H4U, 9023D, J90681, J90C7X, J90H7D,J9027C, J9069F, J90C84, J90H9Y,J90314, J90726, J90D4N, J90J2N,J9034N, J90762, J90E0R, J90J8E,J9038W, J9076A, and J90E29.   HARMONIC¿ HPBLUE Hand Pieces Lot Numbers produced to-date: J9001P, J9053N, J9091G, J90D84,J9005J, J9057E, J90A2C, J90E55,J9010E, J9065U, J90A64, J90F76,J9042G, J90696, J90C36, J90G4C,J9050E, J9086W, J90C7U, and J90H46.

General and Plastic Surgery Devices

Unclassified

No

Worldwide Distribution-USA including: AK,AL,AR,AZ,CA,CO,CT,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA,MD,ME,MI,MN,MO,MS,MT,NCND,NE,NH,NJ,NM,NV,NY,OH,OK,OR,PA,RI,SC,SD,TN,TX,UT,VA,VT,WA,WI,WV, and WY. and the countries of: Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, Ecuador, Egypt, Greece, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Korea (South),Kuwait, Lebanon, Malaysia, Mexico, Netherlands, Antilles, Pakistan, Panama, Puerto Rico, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Taiwan, Thailand, Turkey, United Arab Emirates Uruguay, Venezuela & Yemen.

HPBLUE: HARMONIC¿ Blue Hand Piece; HP054: HARMONIC¿ Hand Piece; Non-Sterile products are individually packed in a poly bag and then placed into an individual carton. Mfr. By: Ethicon Endo-Surgery, LLc, 475 Calle C, Guaynbo, PR 00969. || Indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels.