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

• Reason
• Affected products

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