Z-1099-2007

Power Linear Cutter Reusable Digital Loading Units with Reloads. Common name - Implantable staple. Model...

Name: Z-1099-2007 Power Linear Cutter Reusable Digital Loading Units with Reloads. Common name - Implantable staple. Model...
Creator: Power Medical Interventions, Inc
Published: 2007-05-12
License: https://open.fda.gov/license/

Power Medical Interventions, Inc. / initiated 2007-05-12 / Terminated

FDA source

Power Medical Interventions, Inc began a recall of Power Linear Cutter Reusable Digital Loading Units with Reloads. Common name - Implantable staple. Model number PLC60 on 2007-05-12. The reason FDA records is "Malfunction - improper staple formation". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1099-2007
Status: Terminated
Initiated: 2007-05-12
Posted: 2007-07-24
Terminated: 2007-08-29
Recalling firm: Power Medical Interventions, Inc.
Product: Power Linear Cutter Reusable Digital Loading Units with Reloads. Common name - Implantable staple. Model number PLC60
Product code: GDW Staple, Implantable
Reason for recall: Malfunction - improper staple formation
FDA root cause: Other
Action: The field sales representatives were telephoned 5/14/2007, and instructed to return the affected devices from the customer sites.
Quantity in commerce: 9 units
Distribution: The products were shipped to medical facilities in DC, FL, GA, and NY. The product was also shipped to Germany
Product codes and lots: Model number PLC60. Serial numbers: DO6E0133, DO6E253, DO6E173, DO6E233, DO6E223, DO6E383, DO6G0093, DO6E0043, and DO6E0013.

Product code GDW

K052415Class IIPower Linear Cutter Reusable Digital Loading Units with ReloadsPower Medical Interventions, Inc. / cleared 2005-09-29

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)