Recall Z-2774-2020 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Smith & Nephew, Inc.
Tibial knee prosthesis
| Date | Aug 8, 2020 (initiated Jul 16, 2020) |
| Status | Open, Classified |
| Reason | Due to an inconsistency in the raw material process, specific lots may contain units with internal non-homogenous material defects. |
| Root cause | Nonconforming Material/Component |
| Action | On July 16th the firm send 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. Please provide a copy of the attached Physician Communication to the surgical staff. 3. If y |
| Quantity | 1,845 units |
| Distribution | Domestic Distribution: AL, LA ,MN, KY, AR, MN, GA, TX, WI, NJ, NC, CT, NY, OH, IA, IN, NC, MA, SC, NV, CT, WV, NY, OH, MN, MI, SC, TN, FL, AZ, PA and MO. International Distribution: Austria, Belgium, China, Canada, Switzerland, Colombia, Cyprus, Check Republic, Denmark, Spain, France, Great Britai |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K951987 | GENESIS II TOTAL KNEE SYSTEM Smith & Nephew Richards, Inc., Aug 22, 1995 |