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Health product recall

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

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

A. Twinfix TI 3.5 Suture Anchor with Sutures

Lot or serial number

All lots

Model or catalog number

72200752

72200763

Companies
Manufacturer

Smith and Nephew Inc. Endoscopy Division

130 Forbes Blvd.

Mansfield

02048

Massachusetts

UNITED STATES



B. Twinfix TI 5.0 Suture Anchor with Sutures

Lot or serial number

All lots

Model or catalog number

72200755

72200766

Companies
Manufacturer

Smith & Nephew, Inc. Endoscopy Division



C. Twinfix TI 6.5 Suture Anchor with Sutures

Lot or serial number

All lots

Model or catalog number

72200758

Companies
Manufacturer

Smith and Nephew Inc. Endoscopy Division

130 Forbes Blvd.

Mansfield

02048

Massachusetts

UNITED STATES



D. BioRaptor 2.3 PK Suture Anchor w/ Ultrabraid Suture

Lot or serial number

All lots

Model or catalog number

72201541

72201542

72201543

Companies
Manufacturer

Smith and Nephew Inc. Endoscopy Division

130 Forbes Blvd.

Mansfield

02048

Massachusetts

UNITED STATES



E. Twinfix PK, FT 5.5 mm Suture Anchor

Lot or serial number

All lots

Model or catalog number

72201576

72201577

72201578

Companies
Manufacturer

Smith and Nephew Inc. Endoscopy Division

130 Forbes Blvd.

Mansfield

02048

Massachusetts

UNITED STATES



F. Twinfix PK, FT 6.5 mm Suture Anchor

Lot or serial number

All lots

Model or catalog number

72201681

72201683

Companies
Manufacturer

Smith and Nephew Inc. Endoscopy Division

130 Forbes Blvd.

Mansfield

02048

Massachusetts

UNITED STATES



G. Footprint PK Suture Anchor

Lot or serial number

All lots

Model or catalog number

72201697

72201698

Companies
Manufacturer

Smith and Nephew Inc. Endoscopy Division

130 Forbes Blvd.

Mansfield

02048

Massachusetts

UNITED STATES



H. Footprint PK Suture Anchor w/ AWL

Lot or serial number

All lots

Model or catalog number

72201825

Companies
Manufacturer

Smith and Nephew Inc. Endoscopy Division

130 Forbes Blvd.

Mansfield

02048

Massachusetts

UNITED STATES



I. Preloaded HS Titanium Suture Anchor

Lot or serial number

All lots

Model or catalog number

72200796

Companies
Manufacturer

Smith and Nephew Inc. Endoscopy Division

130 Forbes Blvd.

Mansfield

02048

Massachusetts

UNITED STATES



J. Mini TAC TI 2.0 Anchor

Lot or serial number

All lots

Model or catalog number

72200795

Companies
Manufacturer

Smith and Nephew Inc. Endoscopy Division

130 Forbes Blvd.

Mansfield

02048

Massachusetts

UNITED STATES



K. Twinfix TI Quick-T Fixation System

Lot or serial number

All lots

Model or catalog number

72200767

Companies
Manufacturer

Smith and Nephew Inc. Endoscopy Division

130 Forbes Blvd.

Mansfield

02048

Massachusetts

UNITED STATES



L. Twinfix TI 2.8 Suture Anchor w/ USP #2 Suture

Lot or serial number

All lots

Model or catalog number

72200750

72200762

Companies
Manufacturer

Smith and Nephew Inc. Endoscopy Division

130 Forbes Blvd.

Mansfield

02048

Massachusetts

UNITED STATES



M. Twinfix Ultra PK 4.5 mm Suture Anchor w/ Two Ultrabraid #2 Sutures

Lot or serial number

All lots

Model or catalog number

72202595

72202623

Companies
Manufacturer

Smith and Nephew Inc. Endoscopy Division

130 Forbes Blvd.

Mansfield

02048

Massachusetts

UNITED STATES



N. Twinfix Ultra PK 5.5 mm Suture Anchor w/ Two Ultrabraid #2 Sutures

Lot or serial number

All lots

Model or catalog number

72202599

72202625

Companies
Manufacturer

Smith and Nephew Inc. Endoscopy Division

130 Forbes Blvd.

Mansfield

02048

Massachusetts

UNITED STATES



O. Twinfix Ultra PK 6.5 mm Suture Anchor w/ Two Ultrabraid #2 Sutures

Lot or serial number

All lots

Model or catalog number

72202605

72202630

Companies
Manufacturer

Smith and Nephew Inc. Endoscopy Division

130 Forbes Blvd.

Mansfield

02048

Massachusetts

UNITED STATES



P. BioRaptor Knotless Suture Anchor

Lot or serial number

All lots

Model or catalog number

72202403

Companies
Manufacturer

Smith and Nephew Inc. Endoscopy Division

130 Forbes Blvd.

Mansfield

02048

Massachusetts

UNITED STATES



Q. BioRaptor Knotless Suture Anchor, Hip

Lot or serial number

All lots

Model or catalog number

72202397

Companies
Manufacturer

Smith and Nephew Inc. Endoscopy Division

130 Forbes Blvd.

Mansfield

02048

Massachusetts

UNITED STATES



R. Twinfix Ultra TI 4.5 mm Suture Anchor w/ Sutures

Lot or serial number

All lots

Model or catalog number

72202893

72202894

Companies
Manufacturer

Smith and Nephew Inc. Endoscopy Division

130 Forbes Blvd.

Mansfield

02048

Massachusetts

UNITED STATES



S. Twinfix Ultra TI 5.5 mm Suture Anchor w/ Sutures

Lot or serial number

All lots

Model or catalog number

72202895

72202896

72202897

Companies
Manufacturer

Smith and Nephew Inc. Endoscopy Division

130 Forbes Blvd.

Mansfield

02048

Massachusetts

UNITED STATES



T. Twinfix Ultra TI 6.5 mm Suture Anchor w/ Sutures

Lot or serial number

All lots

Model or catalog number

72202898

72202899

Companies
Manufacturer

Smith and Nephew Inc. Endoscopy Division

130 Forbes Blvd.

Mansfield

02048

Massachusetts

UNITED STATES



U. Footprint Ultra PK Suture Anchor

Lot or serial number

All lots

Model or catalog number

72202901

72202902

Companies
Manufacturer

Smith and Nephew Inc. Endoscopy Division

130 Forbes Blvd.

Mansfield

02048

Massachusetts

UNITED STATES



V. BioRaptor Curved 2.3 PK Suture Anchor

Lot or serial number

All lots

Model or catalog number

72203280

72203281

Companies
Manufacturer

Smith and Nephew Inc. Endoscopy Division

130 Forbes Blvd.

Mansfield

02048

Massachusetts

UNITED STATES



W. Healicoil PK 4.5 mm Suture Anchor w/ Two Ultrabraid (Blue/Cobraid Blue)

Lot or serial number

All lots

Model or catalog number

72203378

Companies
Manufacturer

Smith and Nephew Inc. Endoscopy Division

130 Forbes Blvd.

Mansfield

02048

Massachusetts

UNITED STATES



X. Healicoil PK 5.5 mm Suture Anchor w/ Two Ultrabraid (Blue/Cobraid Blue)

Lot or serial number

All lots

Model or catalog number

72203379

Companies
Manufacturer

Smith and Nephew Inc. Endoscopy Division

130 Forbes Blvd.

Mansfield

02048

Massachusetts

UNITED STATES



Y. Healicoil PK 6.5 mm Suture Anchor w/ Three Ultrabraid (Blue/Cobraid Blue/Cobraid Black)

Lot or serial number

All lots

Model or catalog number

72203380

Companies
Manufacturer

Smith and Nephew Inc. Endoscopy Division

130 Forbes Blvd.

Mansfield

02048

Massachusetts

UNITED STATES


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