Z-0118-2021 Class II Terminated
FDA device recall Z-0118-2021 was initiated by Smith & Nephew, Inc. on September 21, 2020 and is designated Class II. Reason for recall: The anterior locking detail does not meet its design specifications. The recall status is terminated (terminated May 22, 2026). Affected quantity: 47 devices.
Recall Details
- Product Type
- Devices
- Report Date
- October 28, 2020
- Initiation Date
- September 21, 2020
- Termination Date
- May 22, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 47 devices
Product Description
Genesis (GII) - Product Usage: designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are absent or incompetent.
Reason for Recall
The anterior locking detail does not meet its design specifications.
Distribution Pattern
Worldwide distribution - US Nationwide distribution including in the states of CA, NH, NY, GA, MI, TX, IL, OK, LA, OR, FL, AZ, NJ, MO and the countries of AE. BE, BR, CO, DE, ES, FR, GB, HU, IT, PL, PT, TR.
Code Information
Model: 71420966, Lot: 18JY09702