Z-2284-2013 Class II Terminated
FDA device recall Z-2284-2013 was initiated by Medtronic Xomed, Inc. on Aug 23, 2013 and is designated Class II. 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. The recall status is terminated (terminated Nov 7, 2013). Affected quantity: 60.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 2, 2013
- Initiation Date
- Aug 23, 2013
- Termination Date
- Nov 7, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 60
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.
Distribution Pattern
Nationwide Distribution (US), including the states of CA, NE, GA, and IL.
Code Information
REF: 1150000 Lot: 0207029284
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2284-2013
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026