Z-2284-2013Class II

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

Name: Z-2284-2013 Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and...
Creator: Medtronic Xomed, Inc.
Published: 2013-08-23
License: https://open.fda.gov/license/

Medtronic Xomed, Inc. / initiated 2013-08-23 / Terminated / root cause: manufacturing process

FDA source

Medtronic Xomed, Inc. began a recall of Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss on 2013-08-23. FDA classified it as Class II and gives the reason as "One lot of the product was assembled using the Cam Head version of the same prosthesis instead of the Round head Shaft". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2284-2013
Classification: Class II
Status: Terminated
Initiated: 2013-08-23
Posted: 2013-09-26
Terminated: 2013-11-07
Recalling firm: Medtronic Xomed, Inc.
Product: Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss.
Product code: ETA Replacement, Ossicular Prosthesis, Total
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: An "URGENT PRODUCT RECALL" letter was faxed to customers following the initial telephone notification. The letter described the product issue and provided recommended actions. Questions were directed to customer service at 800-874-5797.
Quantity in commerce: 60
Distribution: Nationwide Distribution (US), including the states of CA, NE, GA, and IL.
Product codes and lots: REF: 1150000 Lot: 0207029284

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2284-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2284-2013	Class II	Terminated	Voluntary: Firm initiated	2013-10-02	2013-09-26

Product code ETA

K002897Class IITitanium Middle Ear ProsthesesXomed, Inc. / cleared 2000-10-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)