Health product recall

NATRELLE 133 TISSUE EXPANDER WITH MAGNAFINDER XACT & 21G NEEDLE INFUSION SET (2019-07-29)

Starting date:
July 29, 2019
Posting date:
August 9, 2019
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-70667



Last updated: 2019-08-09

Affected Products

A. NATRELLE 133 TISSUE EXPANDER WITH MAGNAFINDER XACT & 21G NEEDLE INFUSION SET

B. NATRELLE 133FV TISSUE EXPANDER WITH SUTURE TABS WITH MAGNA-FINDER XACT & 21G NEEDLE SET

C. NATRELLE 133FX TISSUE EXPANDER WITH SUTURE TABS WITH MAGNA-FINDER XACT & 21G NEEDLE SET

D. NATRELLE 133LV TISSUE EXPANDER WITH SUTURE TABS WITH MAGNA-FINDER XACT & 21G NEEDLE SET

E. NATRELLE 133MV TISSUE EXPANDER WITH SUTURE TABS WITH MAGNA-FINDER XACT & 21G NEEDLE SET

F. NATRELLE 133MX TISSUE EXPANDER WITH SUTURE TABS WITH MAGNA-FINDER XACT & 21G NEEDLE SET

G. NATRELLE 133SV TISSUE EXPANDER WITH SUTURE TABS WITH MAGNA-FINDER XACT & 21G NEEDLE SET

H. NATRELLE 133SX TISSUE EXPANDER WITH SUTURE TABS WITH MAGNA-FINDER XACT & 21G NEEDLE SET

I. NATRELLE 133 PLUS TISSUE EXPANDER WITH SUTURE TABS

J. NATRELLE 133 PLUS TISSUE EXPANDER

Reason

Allergan has announced a voluntary worldwide recall of Biocell Textured Breast Implants and Tissue Expanders. Allergan is taking this action as a precaution following notification of recently updated global safety information concerning the uncommon incidence of breast implant associated anaplastic large cell lymphoma (BIA_ALCL). Biocell Textured Breast Implants have been previously recalled in Canada May 31, 2019. This notice only impacts Biocell Textured Tissue Expanders. BIA-ALCL is a type of non-hodgkin lymphoma (a cancer that affects the immune system) that may develop many months or years after a breast implant procedure. It is not a cancer of the breast tissue. BIA-ALCL usually presents as an accumulation of fluid (known as seroma fluid) between the implant and the surrounding tissue. While the cause is unknown, possible risk factors and causes for the disease include the high surface area of the implants, genetic factors, and long-term (chronic) inflammation around the implant triggered by factors such as bacteria around the implant.

Affected products

A. NATRELLE 133 TISSUE EXPANDER WITH MAGNAFINDER XACT & 21G NEEDLE INFUSION SET

Lot or serial number

All lots.

Model or catalog number

More than 10 numbers, contact manufacturer.

Companies
Manufacturer

Allergan, Inc.

2525 DUPONT DRIVE

Irvine

92612

California

UNITED STATES


B. NATRELLE 133FV TISSUE EXPANDER WITH SUTURE TABS WITH MAGNA-FINDER XACT & 21G NEEDLE SET

Lot or serial number

All lots.

Model or catalog number

More than 10 numbers, contact manufacturer.

Companies
Manufacturer

Allergan, Inc.

2525 DUPONT DRIVE

Irvine

92612

California

UNITED STATES


C. NATRELLE 133FX TISSUE EXPANDER WITH SUTURE TABS WITH MAGNA-FINDER XACT & 21G NEEDLE SET

Lot or serial number

All lots.

Model or catalog number

133FX-11-T

133FX-12-T

133FX-13-T

133FX-14-T

133FX-15-T

133FX-16-T

Companies
Manufacturer

Allergan, Inc.

2525 DUPONT DRIVE

Irvine

92612

California

UNITED STATES


D. NATRELLE 133LV TISSUE EXPANDER WITH SUTURE TABS WITH MAGNA-FINDER XACT & 21G NEEDLE SET

Lot or serial number

All lots.

Model or catalog number

133LV-11-T

133LV-12-T

133LV-13-T

133LV-14-T

133LV-15-T

133LV-16-T

Companies
Manufacturer

Allergan, Inc.

2525 DUPONT DRIVE

Irvine

92612

California

UNITED STATES


E. NATRELLE 133MV TISSUE EXPANDER WITH SUTURE TABS WITH MAGNA-FINDER XACT & 21G NEEDLE SET

Lot or serial number

All lots.

Model or catalog number

133MV-11-T

133MV-12-T

133MV-13-T

133MV-14-T

133MV-15-T

133MV-16-T

Companies
Manufacturer

Allergan, Inc.

2525 DUPONT DRIVE

Irvine

92612

California

UNITED STATES


F. NATRELLE 133MX TISSUE EXPANDER WITH SUTURE TABS WITH MAGNA-FINDER XACT & 21G NEEDLE SET

Lot or serial number

All lots.

Model or catalog number

133MX-11-T

133MX-12-T

133MX-13-T

133MX-14-T

133MX-15-T

133MX-16-T

Companies
Manufacturer

Allergan, Inc.

2525 DUPONT DRIVE

Irvine

92612

California

UNITED STATES


G. NATRELLE 133SV TISSUE EXPANDER WITH SUTURE TABS WITH MAGNA-FINDER XACT & 21G NEEDLE SET

Lot or serial number

All lots.

Model or catalog number

133SV-11-T

133SV-12-T

133SV-13-T

133SV-14-T

133SV-15-T

133SV-16-T

Companies
Manufacturer

Allergan, Inc.

2525 DUPONT DRIVE

Irvine

92612

California

UNITED STATES


H. NATRELLE 133SX TISSUE EXPANDER WITH SUTURE TABS WITH MAGNA-FINDER XACT & 21G NEEDLE SET

Lot or serial number

All lots.

Model or catalog number

133SX-11-T

133SX-12-T

133SX-13-T

133SX-14-T

133SX-15-T

133SX-16-T

Companies
Manufacturer

Allergan, Inc.

2525 DUPONT DRIVE

Irvine

92612

California

UNITED STATES


I. NATRELLE 133 PLUS TISSUE EXPANDER WITH SUTURE TABS

Lot or serial number

All lots. 

Model or catalog number

More than 10 numbers, contact manufacturer. 

Companies
Manufacturer

Allergan, Inc.

2525 DUPONT DRIVE

Irvine

92612

California

UNITED STATES


J. NATRELLE 133 PLUS TISSUE EXPANDER

Lot or serial number

All lots.

Model or catalog number

More than 10 numbers, contact manufacturer.

Companies
Manufacturer

Allergan, Inc.

2525 DUPONT DRIVE

Irvine

92612

California

UNITED STATES