—#161745

Product

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 product code: GDW — Staple, Implantable
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K983536
Affected lot / code info: CCS25, CCS29

Why it was recalled

There is a potential for the devices to create staples that do not meet formed staple height specifications which can result in malformed staples.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Ethicon Endo-Surgery Inc
Address: 4545 Creek Rd, Blue Ash, Ohio 45242-2803

Distribution

Distribution pattern: China

Timeline

Recall initiated: 2017-10-23
Terminated: 2019-07-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #161745. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.