Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss.
Reported: October 2, 2013 Initiated: August 23, 2013 #Z-2284-2013
Product Description
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.
Details
- Recalling Firm
- Medtronic Xomed, Inc.
- Units Affected
- 60
- Distribution
- Nationwide Distribution (US), including the states of CA, NE, GA, and IL.
- Location
- Jacksonville, FL
Frequently Asked Questions
What product was recalled? ▼
Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss.. Recalled by Medtronic Xomed, Inc.. Units affected: 60.
Why was this product recalled? ▼
One lot of the product was assembled using the Cam Head version of the same prosthesis instead of the Round head Shaft.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 2, 2013. Severity: Moderate. Recall number: Z-2284-2013.
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