Medtronic Xomed, Inc.: Medical Device Recall in 2013 - (Recall #: Z-2284-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss.

Product Classification:

Class II

Date Initiated: August 23, 2013

Date Posted: October 2, 2013

Recall Number: Z-2284-2013

Event ID: 66355

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.

Status: Terminated

Product Quantity: 60

Code Information:

REF: 1150000 Lot: 0207029284

Distribution Pattern:

Nationwide Distribution (US), including the states of CA, NE, GA, and IL.

Voluntary or Mandated:

Voluntary: Firm initiated