Biomet Trauma Phoenix Retrograde Femoral Connecting Bolt Trauma Fixation Systems. Product Usage: The Phoenix Retrograde

FDA device recall Z-1547-2013 · posted 2013-06-15 · Terminated

Recall details

Recalling firm

Biomet, Inc.

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

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

LXH

Quantity affected

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.

Date initiated

2013-04-29

Date posted

2013-06-15

Date terminated

2015-05-06

Location

Warsaw, IN