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