Recall Z-2884-2018
Stryker GmbH · initiated June 27, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: Item Number Lot Number: 1819-1020S K0ACFED; 1819-1220S K0CAEC4; 1832-2824S K0BF6C6; 1832-2828S K0CC742; 1832-3826S K0BF6D2; 1818-1115S K0B906C
Reason for recall
Incomplete seal on the Tyvek lid may compromise the sterility of the device
FDA-determined cause: Packaging process control
Action taken
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.
Details
- Recall number
- Z-2884-2018
- Initiated
- June 27, 2018
- Terminated
- April 13, 2020
- Product code
- HSB – Rod, Fixation, Intramedullary And Accessories
- Quantity
- 38
- Distribution
- US distribution to KY
- Recalling firm
- Stryker GmbH, Selzach