FDA Device recall Z-2284-2013
Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe
- FDA Device
- Class II
- terminated
- Published 2013-10-02
On 2013-10-02 the FDA classified a Class II recall of Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe by Medtronic Xomed, citing one lot of the product was assembled using the Cam Head version of the same prosthesis instead of the Round head Shaft.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2284-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-08-23 |
| Published | 2013-10-02 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Medtronic Xomed |
| Distribution | US |
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.
Identifiers
| code_info | REF: 1150000 Lot: 0207029284 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2284-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.