Medtronic Xomed Recalls Universal Titanium Ear Prosthesis Due to Assembly Error
Medtronic Xomed is recalling 60 units of Universal Titanium Prosthesis because one lot was assembled with the wrong component.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect in an implantable medical device, which poses a risk of harm even though no specific injuries are reported in the source text.
Plain-English summary
Medtronic Xomed, Inc. is recalling 60 units of the Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. This implantable ear prosthesis is indicated for hearing loss. The recall involves one specific lot (Lot: 0207029284, REF: 1150000) that was distributed nationwide, including in California, Nebraska, Georgia, and Illinois.
The recall was initiated because one lot of the product was assembled using the Cam Head version of the prosthesis instead of the intended Round Head Shaft. This is a manufacturing assembly error.
Patients who have received this specific implant should contact their healthcare provider or Medtronic Xomed for instructions on how to proceed. The agency has classified this recall as Class II.
The recalled product
- Product
- Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss.
- Manufacturer
- Medtronic Xomed, Inc.
- Affected units
- 60
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- REF: 1150000 Lot: 0207029284
Distribution
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