Universal Titanium Prosthesis, Round Head, with Flex H/A… recallZ-2284-2013 · Medtronic Xomed, Inc. · initiated Aug 23, 2013
Class II Terminated All recalls posted in September 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Xomed, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
One lot of the product was assembled using the Cam Head version of the same prosthesis instead of the Round head Shaft.
FDA root cause category: Process control
What the company is doing
An "URGENT PRODUCT RECALL" letter was faxed to customers following the initial telephone notification. The letter described the product issue and provided recommended actions. Questions were directed to customer service at 800-874-5797.
Recall details
- Recall number
- Z-2284-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Aug 23, 2013
- Posted by the FDA
- Sep 26, 2013
- Recalling firm
- Medtronic Xomed, Inc.
- Quantity
- 60
- Product code
- ETA
- FDA submissions
- K002897
- Distribution
- Nationwide Distribution (US), including the states of CA, NE, GA, and IL.
Product description
Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss.
Code information (models, lots, serial numbers)
REF: 1150000 Lot: 0207029284
Other devices under the same FDA submission
7 devices cleared under K002897 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- NA 1150001Medtronic Xomed, Inc. · PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT3 reports
- NA 1150000Medtronic Xomed, Inc. · PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT2 reports
- The Big Easy® 1156603Medtronic Xomed, Inc. · PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT2 reports
- The Big Easy® 1156602Medtronic Xomed, Inc. · PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT1 report
- Flex H/A® 1150000Medtronic Xomed, Inc. · PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT1 report
- Big Easy® Piston 1156603Medtronic Xomed, Inc. · PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT1 report
- N/A 1160000Medtronic Xomed, Inc. · PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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