Universal Titanium Prosthesis — Class II medical device recall Z-2284-2013
Terminated recall by Medtronic Xomed, Inc., reported 2013-10-02, distributed nationwide. One lot of the product was assembled using the Cam Head version of the same prosthesis instead of the Round he
| Recall number | Z-2284-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Xomed, Inc., Jacksonville, FL, United States |
| Recall initiated | 2013-08-23 |
| Classified | 2013-09-26 |
| Reported by FDA | 2013-10-02 |
| Terminated | 2013-11-07 |
| Distributed | Nationwide (US) |
| Quantity | 60 |
| Lot numbers | 0207029284 |
| Model numbers | 1150000 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2284-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.