Health product recall

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