Disposable Curved Circular Staplers Product Usage: Staplers have application throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses.
FDA Recall Z-0672-2018 · Posted None
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Recalling FirmEthicon Endo-Surgery Inc
Recall StatusTerminated
Product CodeGDW
Date Initiated2017-10-23
Date Terminated2019-07-18
Product Quantity148.913
Reason for Recall
There is a potential for the devices to create staples that do not meet formed staple height specifications which can result in malformed staples.
Firm Action
Ethicon Johnson & Johnson Affiliates in Asia Pacific will notify their impacted consignees by providing the customer letter through post, email or sales representative visits. The letter identified the affected product, problems and actions to be taken.
Root Cause
Under Investigation by firm
Distribution Pattern
China
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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