—#118267

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.

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Catalog number: 14-442021 and lot number:757910

Why it was recalled

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

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

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.

Timeline

Recall initiated: 2013-04-29
Posted by FDA: 2013-06-15
Terminated: 2015-05-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #118267. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.