Z-0197-2015Class II

Integra Titan Reverse Shoulder System right and left head cutting templates, 142.5 degrees. The Reverse...

Name: Z-0197-2015 Integra Titan Reverse Shoulder System right and left head cutting templates, 142.5 degrees. The Reverse...
Creator: Integra LifeSciences Corp.
Published: 2014-10-24
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2014-10-24 / Terminated / root cause: manufacturing process

FDA source

Integra LifeSciences Corp. began a recall of Integra Titan Reverse Shoulder System right and left head cutting templates, 142.5 degrees. The Reverse Shoulder System Cutting Template, 142.5 degrees is an... on 2014-10-24. FDA classified it as Class II and gives the reason as "A single lot of left and a single lot of right Reverse Shoulder System cutting templates were manufactured incorrectly. Specifically, the threaded handle has been welded backwards on the template resulting in the...". 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-0197-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-24
Posted: 2014-11-08
Terminated: 2015-07-21
Recalling firm: Integra LifeSciences Corporation
Product: Integra Titan Reverse Shoulder System right and left head cutting templates, 142.5 degrees. The Reverse Shoulder System Cutting Template, 142.5 degrees is an accessory for use with the Integra Titan Reverse Shoulder System. It is used to project the osteotomy angle on the humeral head.
Product code: KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Reason for recall: A single lot of left and a single lot of right Reverse Shoulder System cutting templates were manufactured incorrectly. Specifically, the threaded handle has been welded backwards on the template resulting in the cutting angle being the reverse of what it should be.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The recalling firm will notify their consignees via letter delivered by traceable courier service. The consignee will be asked to complete and return a form to the recalling firm stating if they have affected product or not.
Quantity in commerce: 12 units
Distribution: Nationwide Distribution including the states of TX, CA, OH, MS, VA, IL, TN, GA, CA, FL, and AZ.
Product codes and lots: Lot Numbers PM0278 and PM0277

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0197-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0197-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-19	2014-11-07

Product code KWS

K100448Class IIAscension Modular Total Shoulder SystemAscension Orthopedics, Inc. / cleared 2010-08-30

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)