T2 Ankle Arthrodesis Nail, IEFT, Non-Sterile, T2 Femur System - Femoral Nails, T2 Tibial Nail System - Nail Standard (Sterile) and T2 Recon Nail System - Titanium (2018-04-24)
- Starting date:
- April 24, 2018
- Posting date:
- May 4, 2018
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type I
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-66702
Affected products
A. T2 Ankle Arthrodesis Nail, IEFT, Non-Sterile
B. T2 Femur System - Femoral Nails
C. T2 Tibial Nail System - Nail Standard (Sterile)
D. T2 Recon Nail system - Titanium
Reason
On April 9, 2018, the manufacturer discovered that potentially out-of-specification products may have left the factory. To date, there have been no customer complaints logged for this issue. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage.
Affected products
A. T2 Ankle Arthrodesis Nail, IEFT, Non-Sterile
Lot or serial number
K07AFEA
Model or catalog number
1818-1130
Companies
- Manufacturer
-
Stryker Trauma GMBH
Prof.-Kuntscher-Str.1-5
Schoenkirchen
24232
GERMANY
B. T2 Femur System - Femoral Nails
Lot or serial number
K078C77
K07F86C
Model or catalog number
1825-1144S
1825-1240S
Companies
- Manufacturer
-
Stryker Trauma GMBH
Prof.-Kuntscher-Str.1-5
Schoenkirchen
24232
GERMANY
C. T2 Tibial Nail System - Nail Standard (Sterile)
Lot or serial number
K074846
Model or catalog number
1822-1331S
Companies
- Manufacturer
-
Stryker Trauma GMBH
Prof.-Kuntscher-Str.1-5
Schoenkirchen
24232
GERMANY
D. T2 Recon Nail system - Titanium
Lot or serial number
K07F870
Model or catalog number
1844-0940S
Companies
- Manufacturer
-
Stryker Trauma GMBH
Prof.-Kuntscher-Str.1-5
Schoenkirchen
24232
GERMANY