The Food and Drug Administration (FDA) informs the public and all concerned healthcare professionals that Johnson & Johnson Philippines, Inc. has voluntarily recalled specific lots of HARMONIC ACE® Laparoscopic 5mm Diameter Shears + Adaptive Tissue Technology (Specific Lots only for Codes HAR23 and HAR36), with the following impacted lot numbers:
| PRODUCT
NAME |
PRODUCT CODE | PRODUCT LOTS | ||||
| HARMONIC ACE®+ Shears with Adaptive Tissue Technology
(23CM Length) |
HAR23 | P9125C | P93W8A | P94A93 | P94H9V | |
| P93T5J | P93Y4A | P94A94 | P94J28 | |||
| P93T5K | P93Z4X | P94C8R | ||||
| P93V06 | P93Z96 | P94E6U | ||||
| P93W0A | P9400F | P94G1W | ||||
| P93W4Y | P9409V | P94H32 | ||||
| HARMONIC ACE®+ Shears with Adaptive Tissue Technology
(36CM Length) |
HAR36 | N93923 | P93M6P | P93U5N | P94C47 | |
| N9392K | P93M6T | P93U90 | P94C5R | |||
| P9129W | P93N00 | P93U91 | P94C8T | |||
| P91394 | P93N01 | P93V02 | P94D0M | |||
| P9139N | P93N3X | P93V03 | P94D0P | |||
| P9144R | P93N3Y | P93V0V | P94D3J | |||
| P9148K | P93N5A | P93V57 | P94D3K | |||
| P9149J | P93N7H | P93V5T | P94D5G | |||
| P9168K | P93P09 | P93W9R | P94D9K | |||
| P9173R | P93P26 | P93W9X | P94E1Z | |||
| P9174K | P93P2E | P93X2G | P94E20 | |||
| P91795 | P93P7G | P93X2W | P94E3Z | |||
| P91C51 | P93P7H | P93X2X | P94E8W | |||
| P91C83 | P93R0Z | P93X85 | P94F1M | |||
| P91F2X | P93R10 | P93X98 | P94F3A | |||
| P91K69 | P93R4F | P93Y47 | P94F5T | |||
| P91L0H | P93R4G | P93Y48 | P94F6C | |||
| P91L1Y | P93R56 | P93Y8X | P94F7L | |||
| P91L6E | P93R57 | P93Z4T | P94G1H | |||
| P91L6J | P93R6U | P93Z5X | P94G1J | |||
| P9396A | P93R6V | P93Z95 | P94H0K | |||
| P9396C | P93T0X | P94015 | P94H31 | |||
| P9399T | P93T20 | P9414T | P94H4V | |||
| P93A1L | P93T26 | P94A5K | P94H8J | |||
| P93L47 | P93T9L | P94A6A | ||||
| P93L76 | P93U0P | P94C10 | ||||
| P93M5Y | P93U17 | P94C11 | ||||
Ethicon Endo-Surgery, LLC (“Ethicon”), the manufacturer of the above-mentioned products confirmed that some devices contained in theses lots may have been assembled with an internal component that may cause continuous or inadvertent activation of the device.
Based on their medical assessment concluded that this situation may cause inadvertent mechanical or thermal damage to unintended tissue if the continuous or inadvertent activation occurs when used in operative cases.
Distributors, retailers, hospitals and all healthcare professionals / users are advised to discontinue further distribution, sale and use of the said affected medical device product.
For more information and inquiries, please e-mail us at cdrrhr_prsdd@fda.gov.ph. or call us at the Center for Device Regulation, Radiation Health and Research (CDRRHR) hotline (02) 857-1900 local 8301.