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Active Articulation E1 recallZ-1465-2013 · Biomet, Inc. · initiated Apr 26, 2013

Class II Terminated All recalls posted in June 2013

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Biomet, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Labeling mix-ups

What the company is doing

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.

Recall details

Recall number
Z-1465-2013
Recall class
Class II
Status
Terminated
Initiated by the company
Apr 26, 2013
Posted by the FDA
Jun 5, 2013
Recalling firm
Biomet, Inc.
Quantity
8 units
Product code
LPH
FDA submissions
K101336
Distribution
Distributed in New York.

Product description

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

Code information (models, lots, serial numbers)

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.

Other devices under the same FDA submission

20 devices cleared under K101336 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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