Device product
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.
Z-0118-2021
Product summary
- Event
- Event 86496
- Status
- Terminated
- Classification
- Class II
- Quantity
- 47 devices
- Official record key
device-enforcement:Z-0118-2021
Official wording
Reason: The anterior locking detail does not meet its design specifications.
Code information: Model: 71420966, Lot: 18JY09702
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.
Derived failure modes
-
Unknown
The anterior locking detail does not meet its design specifications.