Z-1699-2014Class II

Cochlear Baha Soft tissue gauge 6mm. Reusable instrument used to ensure the soft tissue thickness is equal to...

Name: Z-1699-2014 Cochlear Baha Soft tissue gauge 6mm. Reusable instrument used to ensure the soft tissue thickness is equal to...
Creator: Cochlear Americas Inc.
Published: 2014-04-09
License: https://open.fda.gov/license/

Cochlear Americas / initiated 2014-04-09 / Terminated / root cause: manufacturing process

FDA source

Cochlear Americas Inc. began a recall of Cochlear Baha Soft tissue gauge 6mm. Reusable instrument used to ensure the soft tissue thickness is equal to or less than 6 mm. For use with Baha Attract... on 2014-04-09. FDA classified it as Class II and gives the reason as "Cochlear America is recalling Cochlear Baha Soft Tissue Gauge due to possible manufacturing imperfection in the smooth surface of the metal that could potentially leave residual metal on the patient's skin". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1699-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-09
Posted: 2014-06-02
Terminated: 2014-10-06
Recalling firm: Cochlear Americas
Product: Cochlear Baha Soft tissue gauge 6mm. Reusable instrument used to ensure the soft tissue thickness is equal to or less than 6 mm. For use with Baha Attract hearing system.
Product code: LXB Hearing Aid, Bone Conduction
Reason for recall: Cochlear America is recalling Cochlear Baha Soft Tissue Gauge due to possible manufacturing imperfection in the smooth surface of the metal that could potentially leave residual metal on the patient's skin.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Customers were notified via letter on 4/17/14. This communication included an explanation of the recall and instructions to quarantine and return products.
Quantity in commerce: 288
Distribution: Nationwide Distribution.
Product codes and lots: Outer Package Lot COH523440, COH485876, and COH484221 with/Device Lot No. 131008

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1699-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1699-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-11	2014-06-02

Product code LXB

K131240Class IICochlear Baha Implant System, Cochlear Baha AttractCochlear Americas / cleared 2013-11-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)