Z-2691-2014Class II

Justright Surgical, JustRight 5mm Reload, REFJR-REL25-2.0, Sterile, EO, Rx Only It is a replacement cartridge...

Name: Z-2691-2014 Justright Surgical, JustRight 5mm Reload, REFJR-REL25-2.0, Sterile, EO, Rx Only It is a replacement cartridge...
Creator: Justright Surgical, LLC
Published: 2014-08-27
License: https://open.fda.gov/license/

Bolder Surgical, LLC / initiated 2014-08-27 / Terminated / root cause: manufacturing process

FDA source

Justright Surgical, LLC began a recall of Justright Surgical, JustRight 5mm Reload, REFJR-REL25-2.0, Sterile, EO, Rx Only It is a replacement cartridge used when more than one firing is required during... on 2014-08-27. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2691-2014
Classification: Class II
Status: Terminated
Initiated: 2014-08-27
Posted: 2014-09-23
Terminated: 2014-10-06
Recalling firm: Bolder Surgical, LLC
Product: Justright Surgical, JustRight 5mm Reload, REFJR-REL25-2.0, Sterile, EO, Rx Only It is a replacement cartridge used when more than one firing is required during a surgery.
Product code: GDW Staple, Implantable
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Consignees were notified via letter on August 27, 2014 in addition, the sales rep will hand deliver the Recall Notification on 8/28/14. Acknowledgement Form will be provided and returned products will be sent to STD Med where it will be held in quarantine.
Quantity in commerce: 3 cases containing 36 units
Distribution: Distributed in the states of Colorado, California and New York.
Product codes and lots: Lot: 75FD0417

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2691-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2690-2014	Class II	Terminated	Voluntary: Firm initiated	2014-10-01	2014-09-23
Z-2691-2014	Class II	Terminated	Voluntary: Firm initiated	2014-10-01	2014-09-23

Product code GDW

K132472Class IIJustright 5Mm Stapler, Justright 5Mm ReloadJustright Surgical, LLC / cleared 2014-02-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)