Recall Z-2884-2018 ยท HSB Rod, Fixation, Intramedullary And Accessories
Stryker GmbH
Stryker T2 ANKLE ARTHRODESIS NAIL RIGHT 10MMX200MM Item Number: 1819-1020S T2 ANKLE ARTHRODESIS NAIL RIGHT 12MMX200MM 1819-1220S T2 LONG PROXIMAL HUMERAL NAIL LEFT 240mm1832-2824S T2 LONG PROXIMAL HUMERAL NAIL LEFT 280mm 1832-2828S T2 LONG PROXIMAL HUMERAL NAIL RIGHT 260mm 1832-3826S T2 Ankle Arthrd Nail lft 1818-1115S
| Date | Jun 27, 2018 |
| Status | Terminated |
| Reason | Incomplete seal on the Tyvek lid may compromise the sterility of the device |
| Root cause | Packaging process control |
| Action | Stryker notified consignee via UPS (with return receipt) on June 27, 2018 advising user of the problem, quarantine product and return. Complete and sign the Recall Notification Business Reply Form. Contact (201) 831-6693. |
| Quantity | 38 |
| Distribution | US distribution to KY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051590 | T2 ANKLE ARTHRODESIS NAIL Howmedica Osteonics Corp., Jul 29, 2005 |