FDA Medical Device Recalls (openFDA)
Porex Surgical, Inc.: MEDPOR Surgical Implant * POREX Surgical Products Group * Sterile/EO * Implant, Non-Pyrogenic, For Single Use Only, CAT #6317 DIM 20mm Diameter * Lot xxxxxx * QTY: 1 * Porex Surgical Inc., 15 Dart Road, Newnan, GA 30265 USA
- Recall number
- Z-0712-05
- Recalling firm
- Porex Surgical, Inc.
- Product
- MEDPOR Surgical Implant * POREX Surgical Products Group * Sterile/EO * Implant, Non-Pyrogenic, For Single Use Only, CAT #6317 DIM 20mm Diameter * Lot xxxxxx * QTY: 1 * Porex Surgical Inc., 15 Dart Road, Newnan, GA 30265 USA
- Status
- Terminated
- Initiated
- 2005-03-07
- Posted
- 2005-04-16
- Terminated
- 2005-08-17
- Reason
- The product, which is a 20mm MEDPOR Sphere, was mislabeled in that the package contained 18mm MEDPOR Spheres
- Root cause
- Other
- Action
- On 03/07/2005 and 03/08/2005 consignees were notified via email and telephone. A follow up letter was being sent.
- Quantity
- 30 units
- Distribution
- AZ, IL, NJ and Korea
- Lot, serial or model codes
- Lot A004A02
- 510(k) numbers
- ["K863943"]
- PMA numbers
- not on file
- Product code
- HPZ
- Firm FEI
- 1000131961
- Firm city
- Newnan
- Firm state
- GA
- 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