FAFClass IIIImplant

Prosthesis, Testicular

Gastroenterology, Urology · 21 CFR 876.3750

Call for PMAs on 7/5/95 per 60 FR 17216 on 4/5/95

MDR events153All time

Recalls1All time

Registered firms4Currently listed

510(k) clearances0All time

Recent MDR events

153 adverse event reports on file

Event type breakdown

Injury101

Malfunction48

Unspecified3

Other1

Most-reported manufacturers

Coloplast A/s86 Dow Corning Corp.10 Coloplast Manufacturing Us, Llc8 Coloplast Manufacturing Us Llc6 Mentor Corporation - Minnesota Division6 Mentor Corp - Minnesota Division3 Mentor Corporation - Minnesota Divisi3 Unk3

Recalls

1 recall events for this product code

Coloplast Manufacturing US, LLC
TerminatedDec 27, 2010
Coloplast, Saline Filled Testicular Prosthesis, Sterile R, Manufacturer Coloplast A/S 3050 Denmark.
On April 22, 2010, a decision was made by Coloplast to conduct a field correction based on a report that the Saline Filled Testicular Prosthesis is considered mislabeled. This is solely due to a difference in expiration dates between the Terumo Butterfly Needle included in the kit and the testicular implant. The needle has a 3yr expiration date & the Saline Testicular has a 5yr expiration date.
Z-0820-2011 · View FDA record ↗

Registered firms

4 firms currently registered for this product code

510(k) clearances

0 clearances for this product code

No 510(k) clearances on file for this product code.

PMA approvals

1 premarket approvals for this product code

Coloplast Corp.Jul 19, 2002
P020003 · COLOPLAST SALINE-FILLED TESTICULAR PROSTHESIS