Recall Z-2884-2018— Stryker GmbH

Name: FDA recall Z-2884-2018
Creator: U.S. Food and Drug Administration
Published: 2018-06-27

Class II · Terminated

Class II FDA medical device recall by Stryker GmbH, initiated 2018-06-27, terminated 2020-04-13. It names one FDA 510(k) clearance: K051590. Product: 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. Reason: Incomplete seal on the Tyvek lid may compromise the sterility of the device.

Recalling firm: Stryker GmbH
Classification: Class II
Status: Terminated
Initiated: 2018-06-27
Terminated: 2020-04-13
Firm location: Selzach, Switzerland

510(k) clearances named in this recall

1 on FDA's record

K051590 — T2 ANKLE ARTHRODESIS NAILHowmedica Osteonics Corp.·cleared 2005-07-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Incomplete seal on the Tyvek lid may compromise the sterility of the device

Data sourced from openFDA. This site is unofficial and independent of the FDA.