Integra LifeSciences Corp.: Medical Device Recall in 2014 - (Recall #: Z-0197-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: October 24, 2014

Date Posted: November 19, 2014

Recall Number: Z-0197-2015

Event ID: 69596

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.

Status: Terminated

Product Quantity: 12 units

Code Information:

Lot Numbers PM0278 and PM0277

Distribution Pattern:

Nationwide Distribution including the states of TX, CA, OH, MS, VA, IL, TN, GA, CA, FL, and AZ.

Voluntary or Mandated:

Voluntary: Firm initiated