Z-1567-2022 Class II Ongoing
FDA device recall Z-1567-2022 was initiated by Wright Medical Technology, Inc. on July 27, 2022 and is designated Class II. Reason for recall: An incorrect sizing label was applied to the carton packaging. The recall status is ongoing. Affected quantity: 17 devices.
Recall Details
- Product Type
- Devices
- Report Date
- August 31, 2022
- Initiation Date
- July 27, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17 devices
Product Description
Stryker SWANSON Flexspan Finger Joint Implant W/O Grommets Silicone, Size: 00, REF 4700020, Sterile.
Reason for Recall
An incorrect sizing label was applied to the carton packaging.
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of AZ, CA, FL, GA, NY, PA, and TN. The countries of the Australia, France, the Netherlands, Sweden, and the United Kingdom.
Code Information
Lot numbers 1728375 and 1728376, UDI #00840420121707.