FDA Medical Device Recalls (openFDA)
Power Medical Interventions, Inc: Power Linear Cutter Reusable Digital Loading Units with Reloads. Common name - Implantable staple. Model number PLC60
- Recall number
- Z-1099-2007
- Recalling firm
- Power Medical Interventions, Inc
- Product
- Power Linear Cutter Reusable Digital Loading Units with Reloads. Common name - Implantable staple. Model number PLC60
- Status
- Terminated
- Initiated
- 2007-05-12
- Posted
- 2007-07-24
- Terminated
- 2007-08-29
- Reason
- Malfunction - improper staple formation
- 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
- 9 units
- Distribution
- The products were shipped to medical facilities in DC, FL, GA, and NY. The product was also shipped to Germany
- Lot, serial or model codes
- Model number PLC60. Serial numbers: DO6E0133, DO6E253, DO6E173, DO6E233, DO6E223, DO6E383, DO6G0093, DO6E0043, and DO6E0013.
- 510(k) numbers
- ["K052415"]
- PMA numbers
- not on file
- Product code
- GDW
- Firm FEI
- 3003171713
- Firm city
- Langhorne
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28