Recall Z-1834-2015 ยท NLM Laparoscope, General & Plastic Surgery, Reprocessed
Stryker Sustainability Solutions
Fios First Entry; 5mm x 100mm and 12mm x 100mm; Model #:CTF03 and CTF73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.
| Date | Jun 25, 2015 (initiated Jun 1, 2015) |
| Status | Terminated |
| Reason | Stryker Sustainability Solutions is recalling Trocars because they have received reports indicating that some may fracture at the distal tip resulting in fragments at the surgical site. |
| Root cause | Under Investigation by firm |
| Action | On 06/01/15 a customer notification letter was sent out by the firm. The notification letter instructs customers to stop using the affected lots of the recalled product, and should consider other trocar models reprocesses by Stryker as an alternative. The letter notes that attached is a Effectiveness Check Form and complete list of affected lots shipped to the facility. A Stryker Sustainability Solutions Sales Representative will be sent to check the inventory of the affected lots. Once the inventory is checked the affected lots will be removed. The firm will complete a Recall Effectivene |
| Quantity | 147,351 |
| Distribution | Distributed Nationwide including Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063788 | REPROCESSED ENDOSCOPIC TROCARS AND CANNULAS Ascent Healthcare Solutions, Oct 15, 2007 |