Biomet 3i, LLC: Medical Device Recall in 2015 - (Recall #: Z-1411-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

OSSEOTITE Certain 2 Implant Rx only; 3.25 x 8.5 - 18 mm. Dental Implants.

Product Classification:

Class II

Date Initiated: November 7, 2014

Date Posted: April 22, 2015

Recall Number: Z-1411-2015

Event ID: 70628

Reason for Recall:

Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored.

Status: Terminated

Product Quantity: 620 implants in total

Code Information:

Implant PN # XIFOSM311 Lot # 2014051368 Exp date 12/03/2018

Distribution Pattern:

Worldwide Distribution-US (nationwide) including the states of AL, AZ, CA, CO, CT, DE, FL, GA, IL, KY, LA, MA, MD, MI, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, VA, WA and HI and the countries of Austria, Australia, Canada, France, Germany, Italy, Japan, Netherlands, New Zealand, Portugal, Spain, Turkey, Taiwan, and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated