The Recall Desk
HighFDA (Devices)·Z-2690-2014·Announced 2014-10-01

Justright Surgical Recalls 5mm Staplers Due to Poor Staple Formation

Justright Surgical is recalling specific lots of JustRight 5mm Staplers because they may deliver poor distal staple formation past the end of the knife cut.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a defect that could lead to surgical complications (poor staple formation), representing a risk-of-harm product where specific injury reports are not detailed in the source text.

Plain-English summary

Justright Surgical, LLC is recalling specific lots of JustRight 5mm Stapler and Reload products. The affected products are identified by Lot 75DD0406 and are packaged in cases of 6. The recall involves 3 cases containing 18 units in total.

The recall is being conducted because the products may deliver poor distal staple formation, past the end of the knife cut. The JustRight 5mm Stapler is intended for use in abdominal, gynecologic, pediatric, and thoracic surgery for resection, transection, and creation of anastomosis.

The affected units were distributed in the states of Colorado, California, and New York. Healthcare providers and facilities that have received these products should stop using them and contact Justright Surgical for further instructions.

The recalled product

Product
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
Manufacturer
Justright Surgical, LLC
Category
Medical Device — Surgical Stapler
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot: 75DD0406

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 2 recalled by Justright Surgical, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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