Recall Z-1948-2011 ยท HBX Instrument, Cranioplasty Material Forming
DePuy Mitek, Inc., a Johnson & Johnson Co.
DePuy Mitek FMS Irrigation Intermediary Tube Without One-way Valve Arthroscopy tubing (100 units/box) (International Distribution Only) Product Code: 281102 Fluid Tissue Management
| Date | Apr 12, 2011 (initiated Dec 3, 2010) |
| Status | Terminated |
| Reason | Product sterility may be compromised due to breach in sterile packaging |
| Root cause | Packaging process control |
| Action | Depuy Mitek sent an Urgent Voluntary Product Recall letter dated December 2, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to isolate all inventory of the affected product and call 1-800-382-4682, PROMPT 3, for return good authorization and replacement product. Customers were instructed to return all identified affected product to: DePuy Mitek ATTN: Recall Coordinator 50 Scotland Boulevard Bridgewater, MA 02324 Record their assigned return material authorization (RMA) number on the |
| Quantity | 92,000 units (920 boxes/100) |
| Distribution | Worldwide Distribution - USA (nationwide) and the coutnries of United Arab Emirates, Australia, Belgium, Switzerland, Czech, Denmark, France, UK, Italy, Netherlands, Poland, and Slovakia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K951843 | REF. 4102CV INTERMEDIARY TUBING, REF. 4509CV STERILE ZONE KIT Future Medical Systems, Inc., Jul 14, 1995 |