—#108394

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.

FDA product code: LFL — Instrument, Ultrasonic Surgical
Device class: Class U
Medical specialty: Unknown
510(k) numbers: K063192
Affected lot / code info: 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.

Why it was recalled

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

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Ethicon Endo-Surgery Inc
Address: 4545 Creek Rd, Cincinnati, Ohio 45242-2803

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2012-03-16
Posted by FDA: 2012-05-25
Terminated: 2013-03-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #108394. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.