Recall Z-0849-2014 ยท HSB Rod, Fixation, Intramedullary And Accessories
Stryker Howmedica Osteonics Corp.
Teflon Tube, sterile T2 Humerus System Stryker Trauma GmbH Prof Kuntscher Str 1-5 24232 Sconkidrchen, Germany distributed in the USA by: Stryker Howmedica Osteonics Corp.: Mahwah, NJ 07430 USA 510 K042396 Used in several T2 systems intended to support the exchange of the Ball Tip Guide Wires for Smooth Tip Guide Wires: T2 Tibial Nailing Systems, T2 Femoral Nailing Systems, T2 Ankle Nailing Sys
| Date | Jan 28, 2014 (initiated Nov 7, 2013) |
| Status | Terminated |
| Reason | Stryker became aware during laboratory testing that there is a potential that the seal integrity of the outer pouch (sterile barrier) may be compromised for certain lots of the product Teflon Tube, sterile. |
| Root cause | Process design |
| Action | The firm, Stryker, sent an "URGENT MEDICAL DEVICE REMOVAL" letter dated December 17, 2013 to its customers via e-mail. Preliminary notification letters and Product Accountability Forms were sent via FedEx on November 15, 2013 with return receipt to the Stryker locations. Notification and Product Accountability Forms were sent 12/18/2013 via Fed Ex with return receipt. Updated letters were sent via Fed Ex on 12/19/2013 with return receipt. The letter described the product, problem and actions to be taken. The customers were instructed to quarantine affected devices in local inventory as well |
| Quantity | 34 units |
| Distribution | US Distribution in states of: GA, IL, KY, MI, MO, NJ, TN, UT and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042396 | T2 PROXIMAL HUMERAL NAIL Howmedica Osteonics Corp., Oct 8, 2004 |