Reported Nov 19, 2014 · Terminated
Integra Titan Reverse Shoulder System right and left head cutting templates, 142.5 degrees. The Reverse Shoulder System…
Integra LifeSciences Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Integra LifeSciences Corp. · 311 Enterprise Dr · Plainsboro, NJ · 08536-3344
Is this the product you have?
- 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.
- Lot codes and dates
- Lot Numbers PM0278 and PM0277
- Amount recalled
- 12 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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