Biomet, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1615-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

ExploR 7x26mm Modular Radial Stem, Catalog number 11-210062. Elbow prosthesis orthopedic implant.

Product Classification:

Class II

Date Initiated: April 22, 2014

Date Posted: May 21, 2014

Recall Number: Z-1615-2014

Event ID: 68144

Reason for Recall:

This lot of the ExploR Modular Radial Stem may be missing the wedge ramp threads. If the wedge ramp threads are missing from the stem, the likelihood of the set screw loosening from the radial stem intraoperatively is increased. If the set screw loosens, a revision surgery may be necessary.

Status: Terminated

Product Quantity: 8 devices

Code Information:

Catalog Number: 11-210062 Lot Number Identification: 972230

Distribution Pattern:

US Nationwide Distribution in the states of NY, MD, NC, SC, MI, OR, and NV.

Voluntary or Mandated:

Voluntary: Firm initiated