FDA recall Z-2884-2018

Stryker GmbH · Class II · device

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 for recall

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

Distribution

US distribution to KY

Key facts

Status: Terminated
Initiation date: 2018-06-27
Report date: 2018-08-29
Termination date: 2020-04-13
Voluntary/Mandated: Voluntary: Firm initiated
Location: Selzach, Switzerland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2884-2018