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U.S. Department of Health and Human Services

Class 2 Device Recall Saline Filled Testicular Prosthesis

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 Class 2 Recall
Saline Filled Testicular Prosthesis
see related information
Date Posted December 27, 2010
Recall Status1 Terminated on December 17, 2011
Recall Number Z-0820-2011
Recall Event ID 55976
Premarket Approval
PMA Number
P020003
Product Classification Prosthesis, Testicular - Product Code FAF
Product 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.
Code Information COLOPLAST SALINE-FILLED TESTICULAR SYSTEM LOT NUMBERS ID LOT Number 1. 786681 2. 787652 3. 790324 4. 791715 5. 795502 6. 1536948 7. 1544789 8. 1544791 9. 1544795 10. 1566824 11. 1566832 12. 1566834 13. 1566841 14. 1599021 15. 1635042 16. 1635044 17. 1635046 18. 1635048 19. 1635050 20. 1635052 21. 1635054 22. 1653937 23. 1653939 24. 1654196 25. 1672454 26. 1672456 27. 1672491 28. 1697164 29. 1697166 30. 1706415 31. 1744402 32. 1755277 33. 1767237 34. 1767244 35. 1813045 36. 1813047 37. 1813049 38. 1813051 39. 1822348 40. 1822352 41. 1846127 42. 1846129 43. 1846140 44.1867013 45. 1884873 46. 1884875 47. 1916030 48. 1919212 49. 1919214 50. 1919216 51. 1941770 52. 1941774 53. 1941776 54. 1941778 55. 1983824 56. 1983826 57. 2026772 58. 2026776 59. 2026778 60. 2026834 61. 2071113 62. 2071115 63. 2071117 64. 2071119 65. 2071139 66. 2074043 67. 2079379 68. 2079403 69. 2099145 70. 2099147 71. 2099782 72. 2101520 73. 2101526 74. 2101528 75. 2101584 76. 2101586 77. 2132513 78. 2132515 79. 2132517 80. 2132519 81. 2140442 82. 2140444 83. 2140446 84. 2140448 85. 2174381 86. 2174383 87. 2208887 88. 2208889 89.2208891 90. 2252377 91. 2252379 92. 2252381 93. 2264839 94. 2264841 95. 2264843 96. 2264848 97. 2276876 98. 2276878 99. 2276880 100. 2276882 101. 2313196 102. 2313198 103. 2313200 104. 2313202 105. 2350400 106. 2350402 107. 2350404 108. 2350406 109. 2350408 110. 5529691 111. 5529692 112. 5531496 113. 5580581 114. 5586999 115. 5587251 116. 5590238 117. 5597550 118. 5610612 119. 5612396 120. 5622524 121. 5675309 122. 5677197 123. 5685174 124. 5687319 125. 5687321 126. 5689613 127. 5695126 128. 5701149 129. 5707161 130. 5709326 131. 5710063 132. 5710266 133. 5710268 134. 5710664 135. 5711394 136. 5712307 137. 5714084 138. 5714086 139. 5714087 140. 5714088 141. 5714268 142. 5714829 143. 5715432 144. 5715433 145. 5715434 146. 5715437 147. 5715499 148. 5716316 149. 5716961 150. 5717266 151. 5717268 152. 5717554 153. 5717555 154. 5717705 155. 5717985 156. 5719252 157. 5720929 158. 5723254 159. 5723862 160. 5724292 161. 5724628 162. 5725587 163. 5725588 164. 5725589 165. 5725589 166. 5725591 167. 5725592 168. 5725594 169. 5726567 170. 5726571 171. 5727440 172. 5727441 173. 5727444 Terumo Butterfly Needle Lot Numbers Mfg. lot Number Lot Number 080916 0901190184 080615 0901140227 070414 4132672 070321 4132659 HD20 4129641 HC05 4129640 (Record illegible) 4126828 FF-05 4114382 FE25 4114295 EM18 4109685 EH22 4109365a EK17 4109365b DH07 41009 DH07 40943
Recalling Firm/
Manufacturer
Coloplast Manufacturing US, LLC
1940 Commerce Drive
Mankato, Minnesota 56003
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
MISBRANDING: Labeling False and Misleading
Action 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: usbam@coloplast.com.
Quantity in Commerce 1018
Distribution Worldwide distribution: USA including states of AL, AK, AZ, AR, CO, CT, CA, FL, GA, HI, IL, IN, IA, LA, MD, MA, MI,MN, MS, MO, NJ, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT and WA; and countries of Australia, Canada, Hong Kong and Latin America (Chile, Columbia, Ecuador and Venezuela).
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = FAF and Applicant = COLOPLAST CORP.
PMAs with Product Code = FAF and Applicant = MENTOR CORP.
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