Z-0919-2012

The Artificial Bur Patch is a Temporary Fascial Prothesis. For Single Patient Use only. Use with Negative...

Name: Z-0919-2012 The Artificial Bur Patch is a Temporary Fascial Prothesis. For Single Patient Use only. Use with Negative...
Creator: Novomedicus Llc
Published: 2011-06-22
License: https://open.fda.gov/license/

Novomedicus LLC / initiated 2011-06-22 / Terminated

FDA source

Novomedicus Llc began a recall of The Artificial Bur Patch is a Temporary Fascial Prothesis. For Single Patient Use only. Use with Negative Pressure Wound Dressing. Contents: Large Bur Patch... on 2011-06-22. The reason FDA records is "On 06/22/2011 Novomedicus, FL initiated a recall of the Artificial Bur Hypopack Lot 1010.1, 1102.1, 1103.1 and 5643.2. Cytotoxicity testing revealed a biocompatibility issue. The test results did not represent a health...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0919-2012
Status: Terminated
Initiated: 2011-06-22
Posted: 2012-01-27
Terminated: 2012-08-28
Recalling firm: Novomedicus LLC
Product: The Artificial Bur Patch is a Temporary Fascial Prothesis. For Single Patient Use only. Use with Negative Pressure Wound Dressing. Contents: Large Bur Patch (Sterile: EO), 20cm x 40cm Loop Sheet, 20cm x 40cm Hook Sheet. Sterile: Contents are sterile for maximum two years unless enclosed package has been opened or damaged. Manufactured For: NOVOMEDICUS, LLC P.O. Box 2105 Nokomis, FL 34274. Used for a fascia expander prosthesis to temporarily close the abdominal cavity when regular abdominal closure is not possible; to prevent perfusion impairment of abdominal organs from increases intra-abdominal pressure; and for advanced intra-abdominal pathology requiring more than one abdominal operation to control the disease process.
Product code: FTL Mesh, Surgical, Polymeric
Reason for recall: On 06/22/2011 Novomedicus, FL initiated a recall of the Artificial Bur Hypopack Lot 1010.1, 1102.1, 1103.1 and 5643.2. Cytotoxicity testing revealed a biocompatibility issue. The test results did not represent a health risk.
FDA root cause: Process change control
Action: Novomedicus sent a Medical Device Correction letter dated June 22, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to destroy the inventory, or return the inventory to Novomedicus. If customers decided to return the remaining inventory, Novomedicus would provide TWO replacement kits for each one returned at no additional cost. Customers were asked to complete the attached Return Response form and return to NovoMedicus using the self-addressed and stamped envelope included. For questions regarding this recall call 941-375-4108.
Quantity in commerce: 10 patches
Distribution: Wordwide Distribution - USA including IL, AZ, PA, CT, MO, WI, NY, TX, OR, ME, FL, VA, and MS and the countries of Mexico and Qatar.
Product codes and lots: Lot 54643.2

Product code FTL

K093166Class IIWittmann PatchAperta, LLC / cleared 2009-12-07

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)