Recall Z-0143-2012 ยท JEY Plate, Bone
Bioplate Inc
Bioplate Titanium Fixation System, Sterile Kit. The sterile plate and screw kit configurations for use with the Bioplate Titanium Fixation System are intended for use on non-load bearing fixation, including cranial bone fixation and brow fixation and the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton. Each device is intended for single use only and only i
| Date | Nov 1, 2011 (initiated Mar 31, 2010) |
| Status | Terminated |
| Reason | There is potential defect in seal of the sterile barrier containing the device. |
| Root cause | Process design |
| Action | BIOPLATE sent an URGENT - PRODUCT RECALL NOTIFICATION letter dated March 18, 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 return any recalled product they have at their site and if distributed further they should forward the information contained in the letter to all customers. If a device from one of the lots noted above has already been used, Bioplate would like to be advised of that use. They asked that consignees complete the enclosed Fax form and transmit the requested informa |
| Quantity | 16,020 Individual Kits; 2,226 Boxes. |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Canada, Europe, Japan, Taiwan, Middle East and Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082757 | MODIFIED STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH BIOPLATE TITANIUM FIXATION SYSTEM Bioplate, Inc., Oct 1, 2008 |