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
Z-2884-2018
Product summary
- Firm
- Stryker GmbH
- Event
- Event 80613
- Status
- Terminated
- Classification
- Class II
- Quantity
- 38
- Official record key
device-enforcement:Z-2884-2018
Official wording
Reason: Incomplete seal on the Tyvek lid may compromise the sterility of the device
Code information: Item Number Lot Number: 1819-1020S K0ACFED; 1819-1220S K0CAEC4; 1832-2824S K0BF6C6; 1832-2828S K0CC742; 1832-3826S K0BF6D2; 1818-1115S K0B906C
Distribution pattern: US distribution to KY
Derived failure modes
-
Labeling or packaging
Incomplete seal
-
Sterility assurance
seal on the Tyvek lid may compromise the sterility