RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx only, Sterile R, BIOHORIZONS(R), Dental Imp
FDA device recall Z-0391-2016 · posted 2015-12-07 · Terminated
Recall details
- Recalling firm
- BioHorizons Implant Systems Inc
- Reason for recall
- An incorrect label reading 10.5mm and not the specified 15mm was placed on the implant inner vial packaging.
- Action taken
- BioHorizons sent an Urgent Medical Device Field Correcton letter dated Friday, October 30, 2015, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to complete the enclosed Customer Reply Form and fax to 205-484-2195 or scan to PDF and e-mail to lpbr5015@biohorizons.com. The sole international consignee was notified Monday, 02 November 2015. Customers with questions were instructed to contact the Customer Care Department at 888-246-8338. For questionsn regarding this recall call 205-986-1205.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- DZE
- Quantity affected
- 32 units
- Distribution
- Worldwide Distribution - US including CA, CO, NY, OH, WA, AZ MI, MD, GA, NC, and Internationally to Iran.
- Date initiated
- 2015-10-30
- Date posted
- 2015-12-07
- Date terminated
- 2016-02-04
- Location
- Hoover, AL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BIOHORIZONS INTERNAL IMPLANT SYSTEM (K073268) | BioHorizons Implant Systems, Inc. | 2008-02-08 |