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Recall Observatory FDA recall evidence

Device product

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.

Z-1547-2013

April 29, 2013

Class II

Product summary

Firm
Biomet, Inc.
Event
Event 65210
Status
Terminated
Classification
Class II
Quantity
75
Official record key
device-enforcement:Z-1547-2013

Official wording

Reason: 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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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