Biomet, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1547-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Biomet Trauma Phoenix Retrograde Femoral Connecting Bolt Trauma Fixation Systems. Product Usage: The Phoenix Retrograde Femoral Nail is indicated for alignment, stabilization, and fixation of fractures caused by trauma or disease and the fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity.

Product Classification:

Class II

Date Initiated: April 29, 2013

Date Posted: June 26, 2013

Recall Number: Z-1547-2013

Event ID: 65210

Reason for Recall:

Biomet Trauma ("Biomet") has initiated a recall of Retrograde Femoral Connecting Bolt, which involves Part Number 14-442021. The connecting bolt has an undersized diameter specification that may cause an interference fit with the 4mm hex driver (Part Number: 41024) near the edge of the tolerance. If the 4mm hex driver becomes stuck in the connecting bolt it cannot be taken apart and a delay in su

Status: Terminated

Product Quantity: 75

Code Information:

Catalog number: 14-442021 and lot number:757910

Distribution Pattern:

Worldwide Distribution - USA Nationwide: CA, TX, NY, PA, NJ, FL, OH, MI, CO, SD, IN, MT, GA, and WI. and the countries of Netherlands, Costa Rica, Japan, and San Juan.

Voluntary or Mandated:

Voluntary: Firm initiated