Z-1547-2013 Class II Terminated
FDA device recall Z-1547-2013 was initiated by Biomet, Inc. on Apr 29, 2013 and is designated Class II. 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… The recall status is terminated (terminated May 6, 2015). Affected quantity: 75.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 26, 2013
- Initiation Date
- Apr 29, 2013
- Termination Date
- May 6, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 75
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.
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
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.
Code Information
Catalog number: 14-442021 and lot number:757910
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1547-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026