RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx only, Sterile R, BIOHORIZONS(R), Dental Implant
FDA Recall Z-0391-2016 · Posted 2015-12-07
Recalling FirmBioHorizons Implant Systems Inc
Recall StatusTerminated
Product CodeDZE
Date Initiated2015-10-30
Date Terminated2016-02-04
Product Quantity32 units
Reason for Recall
An incorrect label reading 10.5mm and not the specified 15mm was placed on the implant inner vial packaging.
Firm Action
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 [email protected]. 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
Distribution Pattern
Worldwide Distribution - US including CA, CO, NY, OH, WA, AZ MI, MD, GA, NC, and Internationally to Iran.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.