Z-0391-2016 Class II Terminated
FDA device recall Z-0391-2016 was initiated by BioHorizons Implant Systems Inc on October 30, 2015 and is designated Class II. Reason for recall: An incorrect label reading 10.5mm and not the specified 15mm was placed on the implant inner vial packaging. The recall status is terminated (terminated February 4, 2016). Affected quantity: 32 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 16, 2015
- Initiation Date
- October 30, 2015
- Termination Date
- February 4, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 32 units
Product Description
RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx only, Sterile R, BIOHORIZONS(R), Dental Implant
Reason for Recall
An incorrect label reading 10.5mm and not the specified 15mm was placed on the implant inner vial packaging.
Distribution Pattern
Worldwide Distribution - US including CA, CO, NY, OH, WA, AZ MI, MD, GA, NC, and Internationally to Iran.
Code Information
Lot 1404442