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Recall Observatory FDA recall evidence

Device product

Ligamax 5 mm Endoscopic Multiple Clip Applier

Z-0656-2020

November 07, 2019

Class II

Product summary

Firm
Ethicon Endo-Surgery Inc
Event
Event 84280
Status
Terminated
Classification
Class II
Quantity
48,428
Official record key
device-enforcement:Z-0656-2020

Official wording

Reason: A potential exists that certain LIGAMAX devices within the impacted lots may have small holes in the Tyvek lidding which could result in a breach of sterility.

Code information: Product Code: 11EL5ML Lot Numbers: T93X4R, T93X9D, T93Y2Z, T93Y70, T93Y96, T93Z52, T93Z76, T9401C, T9408F, T94118, T9416M, T9422K, T9426Z, T94402, T94536, T94567, T9461M, T94667, T94721, T94758, T94807, T9484Y, T9487J, T9491A T94A9K, T94C2Z, T94C8N, T94D2N, T94E66, T94F3C, T94F7F, T94G99 T94H1N, T94H78

Distribution pattern: US: Nationwide International: ARGENTINA ARUBA AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA CHINA COLOMBIA DENMARK ESTONIA FINLAND FRANCE GERMANY INDIA INDONESIA IRELAND JAPAN KOREA KUWAIT MALAYSIA MEXICO NETHERLANDS NEW CALEDONIA NEW ZEALAND PANAMA PHILIPPINES PUERTO RICO QATAR SAUDI ARABIA SINGAPORE SLOVENIA SWEDEN SWITZERLAND TAIWAN UK

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    breach of sterility