Biomet 3i, LLC: Medical Device Recall in 2016 - (Recall #: Z-2845-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

3I OSSEOTITE CERTAIN DENTAL IMPLANTS, 4x11.5 mm, Sterile, Rx only.

Product Classification:

Class II

Date Initiated: August 8, 2016

Date Posted: September 28, 2016

Recall Number: Z-2845-2016

Event ID: 74896

Reason for Recall:

Product was incorrectly packaged.

Status: Terminated

Product Quantity: 92 units

Code Information:

Model No: IOSS411; Lot No: 2016031461; UDI: (01)00844868007098(17)210401(10)2016031461.

Distribution Pattern:

US Distributions to the states of : CA and FL., and Worldwide to : Colombia, France, Germany, Italy, and Spain.

Voluntary or Mandated:

Voluntary: Firm initiated