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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Porex Surgical, Inc.
Lot Codes / Batch Numbers
Lot A004A02
Products Sold
Lot A004A02
Porex Surgical, Inc. is recalling MEDPOR Surgical Implant * POREX Surgical Products Group * Sterile/EO * Implant, Non-Pyrogenic, For S due to The product, which is a 20mm MEDPOR Sphere, was mislabeled in that the package contained 18mm MEDPOR Spheres. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The product, which is a 20mm MEDPOR Sphere, was mislabeled in that the package contained 18mm MEDPOR Spheres
Recommended Action
Per FDA guidance
On 03/07/2005 and 03/08/2005 consignees were notified via email and telephone. A follow up letter was being sent.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, IL, NJ
Page updated: Jan 10, 2026