FDA Medical Device Recalls (openFDA)
Medtronic Xomed, Inc.: Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss.
- Recall number
- Z-2284-2013
- 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.
- Status
- Terminated
- Initiated
- 2013-08-23
- Posted
- 2013-09-26
- Terminated
- 2013-11-07
- Reason
- One lot of the product was assembled using the Cam Head version of the same prosthesis instead of the Round head Shaft.
- 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
- 60
- Distribution
- Nationwide Distribution (US), including the states of CA, NE, GA, and IL.
- Lot, serial or model codes
- REF: 1150000 Lot: 0207029284
- 510(k) numbers
- ["K002897"]
- PMA numbers
- not on file
- Product code
- ETA
- Firm FEI
- 1045254
- Firm city
- Jacksonville
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28