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

FDA device recall Z-1465-2013 · posted 2013-06-05 · Terminated

Recall details

Recalling firm

Biomet, Inc.

Reason for recall

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.

Action taken

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.

Root cause

Labeling mix-ups

Status

Terminated

Product code

LPH

Quantity affected

8 units

Distribution

Distributed in New York.

Date initiated

2013-04-26

Date posted

2013-06-05

Date terminated

2013-08-29

Location

Warsaw, IN

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