Z-0772-2021 Class II Terminated
FDA device recall Z-0772-2021 was initiated by Smith & Nephew, Inc. on November 2, 2020 and is designated Class II. Reason for recall: Manufacturing packaging error. The recall status is terminated (terminated January 6, 2023). Affected quantity: 41 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 13, 2021
- Initiation Date
- November 2, 2020
- Termination Date
- January 6, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 41 units
Product Description
Bone fixation nail. TRIGEN INTERTAN - Product Usage: indicated for fractures of the femur including simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, long oblique shaft fractures and segmental shaft fracture;
Reason for Recall
Manufacturing packaging error.
Distribution Pattern
Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, FL, IA, KY, MI, NC, NJ, OH, PA, TN, TX, WA and the countries of AU, CA & GB.
Code Information
Model #: 71675535 & 71675532 Lot #: 20CM25278 & 20DM01466.