Coloplast, Saline Filled Testicular Prosthesis, Sterile R, Manufacturer Coloplast A/S 3050 Denmark. Catalogue Number Description Part Number 450-1323 Extra Small 520600 450-1325 Small 520610 450-1327 Medium 520630 450-1329 Large 520650 The Coloplast Saline-Filled Testicular Prosthesis is intended for use when cosmetic testicular replacement is indicated i.e., in the case of agenesis or following the surgical removal of a testicle. The Butterfly Needle is used to fill the implant with saline.

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.

The recall will extend to field personnel who have control of all SFTP Systems. The product is ordered by the customer (physician and/or hospital) directly from a field sales representative who ships the device to them or drops it off in person. Coloplast sent all Field Personnel an email on April 30, 2010, with a copy of a letter dated April 30, 2010 and a follow-up letter dated May 1, 2010. The letters described the problem and the product involved in the recall. The letters included a list of Corrections Required. This included the field personnel receiving a stock of sterile Butterfly Needles based on their home consignment inventory to be provided for use with all Saline Testicular Implants; Copies of customer letters to be provided with each replacement needle; Changes in all Saline Testicular orders, and Field personnel to administer the details of the correction and make the direct customer contacts. For questions, contact the Customer Service/Field Inventory Representative at 612-337-7859 or email: [email protected]