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Terminated

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

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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