Z-2884-2018 Class II Terminated
FDA device recall Z-2884-2018 was initiated by Stryker GmbH on Jun 27, 2018 and is designated Class II. Reason for recall: Incomplete seal on the Tyvek lid may compromise the sterility of the device The recall status is terminated (terminated Apr 13, 2020). Affected quantity: 38.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 29, 2018
- Initiation Date
- Jun 27, 2018
- Termination Date
- Apr 13, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 38
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
Distribution Pattern
US distribution to KY
Code Information
Item Number Lot Number: 1819-1020S K0ACFED; 1819-1220S K0CAEC4; 1832-2824S K0BF6C6; 1832-2828S K0CC742; 1832-3826S K0BF6D2; 1818-1115S K0B906C
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2884-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026