Reported May 2, 2018 · Terminated
The humeral stems trials are packaged in a kit for Titan Modular Shoulder System under the following labeling: Catalog…
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?
- The humeral stems trials are packaged in a kit for Titan Modular Shoulder
- System under the following labelingCatalog Number Product Description TRL092002506 Humeral Stem Trial, 6mm TRL092002507 Humeral Stem Trial, 7mm TRL092002508 Humeral Stem Trial, 8mm TRL092002509 Humeral Stem Trial, 9mm TRL092002510 Humeral Stem Trial, 10mm TRL092002511 Humeral Stem Trial, 11mm TRL092002512 Humeral Stem Trial, 12mm TRL092002513 Humeral Stem Trial, 13mm TRL092002514 Humeral Stem Trial, 14mm TRL092002515 Humeral Stem Trial, 15mm TRL092002516 Humeral Stem Trial, 16mm
- Lot codes and dates
10 of 10 products
Products covered by this recall # Product as published 1 Lot Numbers: 19419-2 15916-2 15457-2 201274-2 201893-2 2046178 TRL092002508 2 Lot Numbers: 19419-3 15916-3 15457-3 201274-3 201893-3 2046179 TRL092002509 3 Lot Numbers: 19419-4 15916-4 15457-4 201274-4 201893-4 20461710 TRL092002510 4 Lot Numbers: 19419-5 15916-5 15457-5 201274-5 201893-5 20461711 TRL092002511 5 Lot Numbers: 19419-6 15916-6 15457-6 201274-6 201893-6 20461712 TRL092002512 6 Lot Numbers: 19419-7 15916-7 15457-7 201274-7 201893-7 20461713 TRL092002513 7 Lot Numbers: 19419-8 15916-8 15457-8 201274-8 201893-8 20461714 TRL092002514 8 Lot Numbers: 19419-9 15916-9 15457-9 201274-9 201893-9 20461715 TRL092002515 9 Lot Numbers: 19419-10 15916-10 15457-10 201274-10 201893-10 20461716 TRL092002516 10 Lot Numbers: 19419-11 15916-11 15457-11 201274-11 201893-11 20461717 - Amount recalled
- 1619 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
- Nationwide
Why it was recalled
Incidents of stem trial breakage were reported to the firm suggesting that these fractures all occurred during insertion/impaction or extraction of the humeral stem trial whiling preparing the humeral canal and/or trialing. All cases resulted in a delay in surgery, with a variance of medical intervention required.
This product could cause temporary or reversible health problems — stop using it.
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