Recalls from Smith and Nephew Inc. – Endoscopy Division

Starting date:

August 8, 2012

Posting date:

September 3, 2012

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-15832

• Reason
• Affected products

Recalled products

A. Twinfix TI 3.5 Suture Anchor with Sutures
B. Twinfix TI 5.0 Suture Anchor with Sutures
C. Twinfix TI 6.5 Suture Anchor with Sutures
D. BioRaptor 2.3 PK Suture Anchor w/ Ultrabraid Suture
E. Twinfix PK, FT 5.5 mm Suture Anchor
F. Twinfix PK, FT 6.5 mm Suture Anchor
G. Footprint PK Suture Anchor
H. Footprint PK Suture Anchor w/ AWL
I . Preloaded HS Titanium Suture Anchor
J. Mini TAC TI 2.0 Anchor
K. Twinfix TI Quick-T Fixation System
L. Twinfix TI 2.8 Suture Anchor w/ USP #2 Suture
M. Twinfix Ultra PK 4.5 mm Suture Anchor w/ Two Ultrabraid #2 Sutures
N. Twinfix Ultra PK 5.5 mm Suture Anchor w/ Two Ultrabraid #2 Sutures
O. Twinfix Ultra PK 6.5 mm Suture Anchor w/ Two Ultrabraid #2 Sutures
P. BioRaptor Knotless Suture Anchor
Q. BioRaptor Knotless Suture Anchor, Hip
R. Twinfix Ultra TI 4.5 mm Suture Anchor w/ Sutures
S. Twinfix Ultra TI 5.5 mm Suture Anchor w/ Sutures
T. Twinfix Ultra TI 6.5 mm Suture Anchor w/ Sutures
U. Footprint Ultra PK Suture Anchor
V. BioRaptor Curved 2.3 PK Suture Anchor
W. Healicoil PK 4.5 mm Suture Anchor w/ Two Ultrabraid (Blue/Cobraid Blue)
X. Healicoil PK 5.5 mm Suture Anchor w/ Two Ultrabraid (Blue/Cobraid Blue)
Y. Healicoil PK 6.5 mm Suture Anchor w/ Three Ultrabraid (Blue/Cobraid Blue/Cobraid Black)

Reason

Pin holes were detected on the mylar side of the Mylar/Tyvek pouch of some of the packaged units which constituted a breach of the sterile barrier.

Affected products