FDA Medical Device Recalls (openFDA)
Novomedicus Llc: 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.
- Recall number
- Z-0919-2012
- 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.
- Status
- Terminated
- Initiated
- 2011-06-22
- Posted
- 2012-01-27
- Terminated
- 2012-08-28
- Reason
- 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.
- 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
- 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.
- Lot, serial or model codes
- Lot 54643.2
- 510(k) numbers
- ["K093166"]
- PMA numbers
- not on file
- Product code
- FTL
- Firm FEI
- 3008519417
- Firm city
- Nokomis
- Firm state
- FL
- 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