Recall Z-0118-2021 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Smith & Nephew, Inc.
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.
| Date | Sep 21, 2020 |
| Status | Terminated |
| Reason | The anterior locking detail does not meet its design specifications. |
| Root cause | Nonconforming Material/Component |
| Action | On 9/21/20 the firm sent a letter to its consignees with the following instructions: Required Actions: 1. Please inspect your inventory and locate any devices from the listed product and batch numbers enclosed with this Urgent Medical Device Recall Notice, and quarantine them immediately. a. If you are a sales rep or distributor, you must notify your customers of the field action and ensure that the required actions are complete. b. Include the customers account number and name in the table below. 2. If you have no product to return, please put an X in the appropriate location below. 3. If yo |
| Quantity | 47 devices |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K962137 | GENESIS II CONSTRAINED SYSTEM Smith & Nephew Richards, Inc., Aug 2, 1996 |