—#118256

Product

Active Articulation E1. Intended for use with either primary or revision hip arthroplasty.

FDA product code: LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K101336
Affected lot / code info: Part numbers: EP-200162, EP-200162, EP-200164, and EP-200166 with Lot numbers: 027050, 101470, 115950, 101480, 247990, 948810, 967270, 027070, 287820, 729870, and 860880.

Why it was recalled

Biomet is recalling Active Articulation E1 Hip Bearing implants. Biomet has initiated this action following an investigation which identified that outer label indicates two conflicting O.D. sizes while the inner labels indicate an incorrect O.D. size. The implant itself is etched with the correct O.D. size.

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

Biomet sent an Urgent Medical Device Recall letter dated April 26, 2013 to consignees detailing that the outer label indicates two conflicting O.D. sizes while the inner labels indicate an incorrect O.D. size. This action requires the immediate location and discontinued use of the product and its return to Biomet. Ciustomers were advised to: Immediately locate and remove the identified device(s) listed from circulation . -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. This letter MUST be given to hospital personnel responsible for receiving recall notices. However, you are charged with the location and return of these products.

Recalling firm

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

Distribution

Distribution pattern: Distributed in New York.

Timeline

Recall initiated: 2013-04-26
Posted by FDA: 2013-06-05
Terminated: 2013-08-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #118256. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.