Product Wiki · Recalls · U.S. FDA — Device Enforcement

Justright Surgical, JustRight 5mm Stapler, REF JR-ST25-2.0, Sterile, EO, Rx Only, JR-ST25-2.0 product is packaged in cases of 6. The JustRight 5mm Stapler is intended for use in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection, and creation of anastomosis. — recall Z-2690-2014

U.S. FDA — Device Enforcement · United States · 2014-08-27 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2690-2014
Date of alert: 2014-08-27
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Justright Surgical, LLC
Product category: device
Product type: Devices

Reported risk: JustRight Surgical is recalling specific lots of JustRight 5mm Stapler and Reload products because they may deliver poor distal staple formation, past the end of the knife cut.

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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