Integra Titan Reverse Shoulder System right and left head cutting… — Class II medical device recall Z-0197-2015
Terminated recall by Integra LifeSciences Corp., reported 2014-11-19, distributed nationwide. A single lot of left and a single lot of right Reverse Shoulder System cutting templates were manufactured inc
| Recall number | Z-0197-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp., Plainsboro, NJ, United States |
| Recall initiated | 2014-10-24 |
| Classified | 2014-11-07 |
| Reported by FDA | 2014-11-19 |
| Terminated | 2015-07-21 |
| Distributed | Nationwide (US) |
| Quantity | 12 units |
| Lot numbers | PM0277, PM0278 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0197-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.