RegWardenFDA facility compliance records
Facility

RESORBA Medical GmbH

2 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2015: 1 recalls; 2024: 1 recalls12015201620172018201920202021202220231202420252026
  • Recalls (2)

Devices registered here (1)

  • Suture, Nonabsorbable, Synthetic, Polyethylene
    Product code GAT (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.5000

Recalls & enforcement

  • Class IIOngoing2024-10-01
    Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier.
  • Class IITerminated2015-01-15
    On 08 January 2015 AMS Sole Customer for the products notified AMS of the issue after discovering the misplaced IFUs during its review of packaging in its warehouse

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “RESORBA Medical GmbH (FEI 3002807993) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002807993-resorba-medical-gmbh/

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