—#164339

Product

HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 36cm Length / Curved, Product Code HAR36, GTIN 10705036014447 Product Usage: The HARMONIC ACE Shears + Adaptive Tissue Technology are 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 in general, plastic, pediatric, gynecologic, urologic, thoracic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures.

FDA product code: LFL — Instrument, Ultrasonic Surgical
Device class: Class U
Medical specialty: Unknown
510(k) numbers: K121550
Affected lot / code info: N93923, N9392K, N93978, P9123A, P9129W, P91301, P91394, P9139N, P9144R, P9149J, P9148K, P9168K, P9173R, P9174K, P91795, P91C51, P91C83, P91D30, P91K68, P91L0H, P91K69, P91L0J, P91L1Y, P91L6E, P91L6J, P9396A, P9396C, P9399T, P93A1L, P93M0K, P93M0L, P93N01, P93M5Y, P93N5A, P93N3X, P93N3Y, P93P09, P93P26, P93P7H, P93R10, P93R4F, P93R4G, P93R56, P93R6V, P93T0X, P93T9L, P93T9M, P93U17, P93U91, P93V0V, P93V0W, P93V5T, P93V02, P93V03, P93X4E, P93X65, P93X85, P93X98, P93X9E, P93Y47, P93Y48, P93Y8X, P93X2X, P93Z95, P93Z4T, P93Z5X, P94015, P9405H, P9409W, P9410Z, P9414T, P94A5K, P94A6A, P94C11, P94C47, P94C5R, P94C8T, P94D3J, P94D3K, P94D5G, P94D7Z, P94D9K, P94E1Z, P94E20, P94E3Z, P94E8W, P94F1M, P94F3A, P94F5T, P94F6C, P94F7L, P94G1G, P94G1H, P94G1J, P94H0J, P94H0K, P94H31, P94H4V, P94H8J, P9139V, P91749, P9179U, P91F2X, P91L1Z, P93L47, P93L76, P93M6T, P93M6P, P93N00, P93N7G, P93N7H, P93P2E, P93P7G, P93R0Z, P93R57, P93R6U, P93T20, P93T26, P93U0P, P93U5N, P93U90, P93V57, P93W9X, P93X2G, P93W9R, P93X2W, P94C10, P94D0M, P94D0P, P94J29

Why it was recalled

The devices may have been assembled with an internal component that may cause continuous or inadvertent activation of the device.

Root cause (FDA determination)

Other

Action the firm took

Urgent Voluntary Medical Device Recall (Removal) letters were distributed on 5/3/18. The letters included the following instructions for customers: 1. Examine your inventory immediately to determine if you have product lots subject to this recall on hand and quarantine such product(s). 2. Remove the product lots subject to this recall and communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. If any product lots subject to this recall have been forwarded to another facility, contact that facility to arrange return. 3. Complete the Business Reply Form (BRF) (Attachment 2) confirming receipt of this notice and fax or email it to Stericycle at 1-866-913-0665 or ethicon5872@stericycle.com within three (3) business days. Please return the BRF even if you do not have the product lots subject to this recall. 4. Keep this notice visibly posted for awareness until all product lots subject to this recall have been returned to Stericycle. While processing your returns, please maintain a copy of this notice with the product lots subject to this recall and keep a copy for your records. 5. Customers are required to return all unused HARMONIC ACE+ Shears with Adaptive Tissue Technology product lots subject to this recall that are in their inventory immediately. Only unused HARMONIC ACE+ Shears with Adaptive Tissue Technology product lots subject to this recall returned by August 31, 2018 will be eligible for replacement. Any unused HARMONIC ACE+Shears with Adaptive Tissue Technology product lots subject to this recall returned after August 31, 2018 will not be eligible for replacement. 6. To return unused HARMONIC ACE+ Shears with Adaptive Tissue Technology product lots subject to this recall, photocopy the completed BRF, place it in the box with the subject products, and affix the pre-paid authorized shipping label included with this recall notification letter. Ethicon wi

Recalling firm

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

Distribution

Distribution pattern: Worldwide distribution - US Nationwide. The devices were distributed to the following foreign countries: Algeria, Angola, Argentina, Armenia, Australia, Austria, Belgium, Bolivia, Bosnia, Brazil, Bulgaria, Canada, Chile, China, Columbia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, UK, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Malta, Martinique, Mayotte, Mexico, Mongolia, Montenegro, Morocco, Netherlands, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tobago, Turkey, Ukraine, UAE, Uruguay, Vietnam.

Timeline

Recall initiated: 2018-05-03
Terminated: 2019-11-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #164339. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.