Class II — Integra LifeSciences Corp.
| Recalling firm | Integra LifeSciences Corporation |
|---|---|
| Registered facility | View this company's 15 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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. |
| Quantity | 12 units |
| Distribution | Nationwide Distribution including the states of TX, CA, OH, MS, VA, IL, TN, GA, CA, FL, and AZ. |
| Initiated | 2014-10-24 |
| Classified | 2014-11-07 |
| Terminated | 2015-07-21 |
| Recall number | Z-0197-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Integra LifeSciences Corp. (Z-0197-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/69596/
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