The Artificial Bur Patch is a Temporary Fascial Prothesis. For Single Patient Use only. Use with Negative Pressure Wound
FDA device recall Z-0919-2012 · posted 2012-01-27 · Terminated
Recall details
- Recalling firm
- Novomedicus Llc
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- FTL
- Quantity affected
- 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.
- Date initiated
- 2011-06-22
- Date posted
- 2012-01-27
- Date terminated
- 2012-08-28
- Location
- Nokomis, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| WITTMANN PATCH (K093166) | Aperta, LLC | 2009-12-07 |