Universal Titanium Prosthesis recall
Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss.
Why was Universal Titanium Prosthesis recalled?
One lot of the product was assembled using the Cam Head version of the same prosthesis instead of the Round head Shaft.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
REF: 1150000 Lot: 0207029284
- Product
- Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss.
- Recalling firm
- Medtronic Xomed, Inc.
- Quantity
- 60
- Distribution
- Nationwide Distribution (US), including the states of CA, NE, GA, and IL.
- Recall date
- October 2, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)