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SILIMED IMPLANTS (2015-09-17)
- Starting date:
- September 17, 2015
- Posting date:
- October 22, 2015
- 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-55534
Affected Products
- A. GLUTEAL IMPLANT, SILICONE ELASTOMER, TEXTURED SURFACE OVAL
- B. GASTRIC BALLOON
- C. VESICAL CONFORMER
- D. GLUTEAL IMPLANT, SILICONE ELASTOMER, SMOOTH SURFACE ROUND
- E. INFLATABLE VAGINAL STENT
- F. CHIN IMPLANT, SILICONE ELASTOMER
- G. 423686 TESTICULAR IMPLANT, SILICONE ELASTOMER
- H. CALF IMPLANT, SILICONE ELASTOMER
- I. PECTORAL IMPLANT, SILICONE ELASTOMER
Reason
On September 17th 2015, Silimed had its Conformité Européene (CE) mark suspended due to the discovery of microscopic particles on the surface of some of its implants tested by Technischer Überwachungsverein (TÜVs) in a recent audit. Silimed has been given a limit period of 90 days to produce technical reports and treat the non-conformities reported.
Affected products
A. GLUTEAL IMPLANT, SILICONE ELASTOMER, TEXTURED SURFACE OVAL
Lot or serial number
All lots.
Model or catalog number
20922-155U
20922-160U
20922-165U
20922-168U
20922-170U
20942-180U
Companies
- Manufacturer
-
SILIMED INDUSTRIA DE IMPLANTES LTDA
RUA FIGUEIREDO ROCHA, 374 E 494
VIGARIO GERAL
21240-660
BRAZIL
B.GASTRIC BALLOON
Lot or serial number
All lots.
Model or catalog number
6330-350
Companies
- Manufacturer
-
SILIMED INDUSTRIA DE IMPLANTES LTDA
RUA FIGUEIREDO ROCHA, 374 E 494
VIGARIO GERAL
21240-660
BRAZIL
C. VESICAL CONFORMER
Lot or serial number
All lots.
Model or catalog number
3300-100
3300-270
Companies
- Manufacturer
-
SILIMED INDUSTRIA DE IMPLANTES LTDA
RUA FIGUEIREDO ROCHA, 374 E 494
VIGARIO GERAL
21240-660
BRAZIL
D. GLUTEAL IMPLANT, SILICONE ELASTOMER, SMOOTH SURFACE ROUND
Lot or serial number
All lots.
Model or catalog number
932-115U
932-120U
932-125U
932-130U
Companies
- Manufacturer
-
SILIMED INDUSTRIA DE IMPLANTES LTDA
RUA FIGUEIREDO ROCHA, 374 E 494
VIGARIO GERAL
21240-660
BRAZIL
E. INFLATABLE VAGINAL STENT
Lot or serial number
All lots.
Model or catalog number
3521-095
3521-120
3521-140
Companies
- Manufacturer
-
SILIMED INDUSTRIA DE IMPLANTES LTDA
RUA FIGUEIREDO ROCHA, 374 E 494
VIGARIO GERAL
21240-660
BRAZIL
F. CHIN IMPLANT, SILICONE ELASTOMER
Lot or serial number
All lots.
Model or catalog number
10-045
10-050
15-060
Companies
- Manufacturer
-
SILIMED INDUSTRIA DE IMPLANTES LTDA
RUA FIGUEIREDO ROCHA, 374 E 494
VIGARIO GERAL
21240-660
BRAZIL
G. 423686 TESTICULAR IMPLANT, SILICONE ELASTOMER
Lot or serial number
All lots.
Model or catalog number
3232-030
3232-040
3232-045
3232-050
Companies
- Manufacturer
-
SILIMED INDUSTRIA DE IMPLANTES LTDA
RUA FIGUEIREDO ROCHA, 374 E 494
VIGARIO GERAL
21240-660
BRAZIL
H. CALF IMPLANT, SILICONE ELASTOMER
Lot or serial number
All lots.
Model or catalog number
402-065U
402-100U
412-150U
412-200U
412-230U
Companies
- Manufacturer
-
SILIMED INDUSTRIA DE IMPLANTES LTDA
RUA FIGUEIREDO ROCHA, 374 E 494
VIGARIO GERAL
21240-660
BRAZIL
I. PECTORAL IMPLANT, SILICONE ELASTOMER
Lot or serial number
All lots.
Model or catalog number
20132-150DU
20132-150EU
20132-160DU
20132-160EU
20132-170DU
20132-170EU
Companies
- Manufacturer
-
SILIMED INDUSTRIA DE IMPLANTES LTDA
RUA FIGUEIREDO ROCHA, 374 E 494
VIGARIO GERAL
21240-660
BRAZIL