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Terminated

HARMONIC ACE+ 7 Laparoscopic Shears with Advanced Hemostasis (23cm, 36cm, 45cm length), Ethicon Endo-Surgery. Indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired.

FDA Recall Z-0278-2016 · Posted 2015-11-16

Recalling FirmEthicon Endo-Surgery Inc
Recall StatusTerminated
Product CodeLFL
Date Initiated2015-09-23
Date Terminated2016-11-01
Product Quantity441,490 pieces

Reason for Recall

Complaints of holes in Tyvek which can compromise the sterile barrier provided by the packaging.

Firm Action

On October 5, 2015, the firm sent Urgent Medical Device Recall Removal Letters to their customers.

Root Cause

Device Design

Distribution Pattern

Distributed US (nationwide) including the District of Columbia & Puerto Rico and in the countries of ARUBA, AUSTRALIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, ECUADOR, HONG KONG, INDIA, JAPAN, KOREA, MALAYSIA, MEXICO, PANAMA, PERU, PHILIPPINES, SINGAPORE, SINGAPORE, THAILAND, TAIWAN & VIETNAM.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K132612HARMONIC ACE+ SHEARS 23 CM LENGTH WITH ADVANCED HEMOSTASIS, HARMONIC ACE + LAPAROSCOPIC SHEARS 36 CM LENGTH WITH ADVANCEEthicon Endo-Surgery, LLC · 2013-10-17

Official Source

View FDA Recall →

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

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