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Terminated

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.

FDA Recall Z-0919-2012 · Posted 2012-01-27

Recalling FirmNovomedicus Llc
Recall StatusTerminated
Product CodeFTL
Date Initiated2011-06-22
Date Terminated2012-08-28
Product Quantity10 patches

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.

Firm 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.

Root Cause

Process change control

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K093166WITTMANN PATCHAperta, LLC · 2009-12-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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