Terminated

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 Recall Z-1673-2012 · Posted 2012-05-25

Recalling FirmEthicon Endo-Surgery Inc

Recall StatusTerminated

Product CodeLFL

Date Initiated2012-03-16

Date Terminated2013-03-05

Product Quantity1896 instruments

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

Firm 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.

Root Cause

Nonconforming Material/Component

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K063192HARMONIC FOCUS CURVED SHEARS AND TORQUE WRENCH, HARMONIC BLUE HAND PIECE AND TEST TIPEthicon Endo-Surgery, LLC · 2007-01-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.