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U.S. Department of Health and Human Services

Class 2 Device Recall HARMONIC Blue Hand Piece & HARMONIC Hand Piece

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  Class 2 Device Recall HARMONIC Blue Hand Piece & HARMONIC Hand Piece see related information
Date Initiated by Firm March 16, 2012
Date Posted May 25, 2012
Recall Status1 Terminated 3 on March 05, 2013
Recall Number Z-1673-2012
Recall Event ID 61540
510(K)Number K063192  
Product Classification Instrument, ultrasonic surgical - Product Code LFL
Product 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.
Code Information 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. 
Recalling Firm/
Ethicon Endo-Surgery Inc
4545 Creek Rd
Cincinnati OH 45242-2803
For Additional Information Contact Thomas A. Morris
Manufacturer Reason
for Recall
Ethicon Endo-Surgery initiated a voluntary recall due to some lot numbers of the HARMONIC¿ Hand Piece (HP054) and the HARMONIC¿ Blue Hand Piece (HPBLUE), which impacts their compatibility with the HARMONIC¿ Generator 300 (GEN04). The problem occurs after successful set up and initial use of HARMONIC¿ Hand Pieces (HP054 and HPBLUE) with the Generator 300 (GEN04). The procedure is interrupted when
FDA Determined
Cause 2
Nonconforming Material/Component
Action Ethicon Endo-Surgery Inc sent an URGENT: Product Correction Notification letter dated March 2012 to all affected customers. The letter identified the product, the problem, the action to be taken by the customer. Labels were enclosed that are used to identify the recalled product. Customers were instructed to fill out the Business Reply Form and fax it to Stericycle at 1-888-912-7091 within three business days for a credit. For questions regarding this recall call 513-337-3419.
Quantity in Commerce 1896 instruments
Distribution 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LFL and Original Applicant = ETHICON ENDO-SURGERY, LLC