Recall Z-0920-2012 ยท FTL Mesh, Surgical, Polymeric
Novomedicus Llc
The Artificial Bur HypoPack is a Temporary Fascial Prothesis with Hypobaric Wound Dressing. For Single Patient Use only. Contents: 1. Large Bur Patch (Sterile: EO), 20cm x 40cm Loop Sheet, 20cm x 40cm Hook Sheet. 2. 60cm x 85 cm Steri Drape 3. Drain with Connector 4. 4 x Gauze Rolls Sterile: Contents are sterile for maximum two years unless enclosed package has been opened or damaged. Used for a
| Date | Jan 27, 2012 (initiated Jun 22, 2011) |
| Status | Terminated |
| 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 quest |
| Quantity | 37 kits |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093166 | WITTMANN PATCH Aperta, LLC, Dec 7, 2009 |