CLASS II Device recall · Reported 2 Oct 2013 · FDA Enforcement Report
Universal Titanium Prosthesis, Round Head recalled by Medtronic Xomed
Medtronic Xomed is recalling Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe, distributed nationwide in the US. The recall was initiated on 23 Aug 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2284-2013
- FDA event ID
- 66355
- Recalling firm
- Medtronic Xomed, Jacksonville, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Aug 2013
- FDA classified
- 26 Sep 2013
- Reported
- 2 Oct 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 23 Aug 2013 | Recall initiated by company | |
| 26 Sep 2013 | Classified by FDA | +34 days |
| 2 Oct 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss.
Where it was distributed
Nationwide Distribution (US), including the states of CA, NE, GA, and IL.
Questions about this recall
Why was it recalled?
One lot of the product was assembled using the Cam Head version of the same prosthesis instead of the Round head Shaft.
Which lots are affected?
REF: 1150000 Lot: 0207029284
Where was it sold?
Nationwide Distribution (US), including the states of CA, NE, GA, and IL.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Medtronic Xomed
All 25| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | IPC Powerease System recalled by Medtronic Xomed | Medtronic Xomed | Other | 25 states |
| Device | CLASS II | NIM Vital Nerve Monitoring System: Console NIM4CM01 NIM recalled | Medtronic Xomed | Device Malfunction | Nationwide |
| Device | CLASS II | Medtronic ENT Ultra Round Steel Cutting Bur recalled by Medtronic Xomed | Medtronic Xomed | Other | FL |
| Device | CLASS II | NIM TriVantage EMG Endotracheal Tubes recalled by Medtronic Xomed | Medtronic Xomed | Other | FL |
| Device | CLASS I | NIM EMG Endotracheal Tube, Part Numbers: a) recalled by Medtronic Xomed | Medtronic Xomed | Other | Nationwide |
Other Other Medical Devices recalls
All 13,884| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | NOxBOXi Nitric Oxide Delivery System recalled | Noxbox | Device Malfunction | Nationwide |
| Device | CLASS II | Palacos R pro recalled by Heraeus Medical GmbH (Dental | Heraeus Medical GmbH (Dental Division) | Packaging Defects | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065 recalled | Percussionaire | Other | Nationwide |
| Device | CLASS II | Positron Emission Tomography and Computed Tomography System recalled | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV-1C recalled by Percussionaire | Percussionaire | Other | Nationwide |