Bioplate Titanium Fixation System, Sterile Kit. The sterile plate and screw kit configurations for use with the Bioplate
FDA device recall Z-0143-2012 · posted 2011-11-01 · Terminated
Recall details
- Recalling firm
- Bioplate Inc
- Reason for recall
- There is potential defect in seal of the sterile barrier containing the device.
- Action taken
- 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 information to them as soon as possible at (310) 815-2126. Returned recalled product was to be sent to: Bioplate 3643 Lenawee Avenue Los Angeles, CA 90016 3643 Lenawee Avenue, Los Angeles, CA 90016 For any questions regarding this recall call (310) 815-2100.
- Root cause
- Process design
- Status
- Terminated
- Product code
- JEY
- Quantity affected
- 16,020 Individual Kits; 2,226 Boxes.
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of Canada, Europe, Japan, Taiwan, Middle East and Australia.
- Date initiated
- 2010-03-31
- Date posted
- 2011-11-01
- Date terminated
- 2012-04-04
- Location
- Los Angeles, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFIED STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH BIOPLATE TITANIUM FIXATION SYSTEM (K082757) | Bioplate, Inc. | 2008-10-01 |