FDA Recall
Terminated
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
Recall: Z-2884-2018
·
Initiated June 27, 2018
Recall
- Recall Number
- Z-2884-2018
- Event Number
- 80613
- Firm
- Stryker GmbH Bohnackerweg 1 Selzach Switzerland
- FEI Number
- 3002807830
- Product Code
- HSB
- Status
- Terminated
- Root Cause
- Packaging process control
- Initiated
- June 27, 2018
- Terminated
- April 13, 2020
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
Incomplete seal on the Tyvek lid may compromise the sterility of the device
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.
Distribution
US distribution to KY
Quantity
38