| Class 2 Device Recall Phoenix Retrograde Femoral Nail | |
Date Initiated by Firm | April 29, 2013 |
Date Posted | June 15, 2013 |
Recall Status1 |
Terminated 3 on May 06, 2015 |
Recall Number | Z-1547-2013 |
Recall Event ID |
65210 |
Product Classification |
Orthopedic manual surgical instrument - Product Code LXH
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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. |
Code Information |
Catalog number: 14-442021 and lot number:757910 |
Recalling Firm/ Manufacturer |
Biomet, Inc. 56 E Bell Dr Warsaw IN 46582-6989
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For Additional Information Contact | Audrey Daenzer 574-267-6639 Ext. 1676 |
Manufacturer 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 |
FDA Determined Cause 2 | Device Design |
Action | Biomet sent an URGENT MEDICAL DEVICE RECALL notification letter dated April 29, 2013 to all affected customers. The letter identifed the affected product, problem and actions to be taken. The letter instructed customers to: immediately locate and remove the identified affected device(s), carefully follow the instructions on the enclosed "FAX Back Response Form", fax a copy of the Response Form to 574-372-1683 prior to return of product, use priority carrier for your shipment, if you have further distributed this product, you MUST notify hospital personnel of this action via the enclosed "Dear O.R. Manager" notice. For questions call 574-372-1570. |
Quantity in Commerce | 75 |
Distribution | 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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