Recall Z-2284-2013— Medtronic Xomed, Inc.

Name: FDA recall Z-2284-2013
Creator: U.S. Food and Drug Administration
Published: 2013-08-23

Class II · Terminated

Class II FDA medical device recall by Medtronic Xomed, Inc., initiated 2013-08-23, terminated 2013-11-07. It names one FDA 510(k) clearance: K002897. Product: Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss.. Reason: One lot of the product was assembled using the Cam Head version of the same prosthesis instead of the Round head Shaft..

Recalling firm: Medtronic Xomed, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-08-23
Terminated: 2013-11-07
Firm location: Jacksonville, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K002897 — TITANIUM MIDDLE EAR PROSTHESESXomed, Inc.·cleared 2000-10-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss.

Reason for recall

One lot of the product was assembled using the Cam Head version of the same prosthesis instead of the Round head Shaft.

Data sourced from openFDA. This site is unofficial and independent of the FDA.