Recall Z-1543-2016 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Smith & Nephew, Inc.
TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 10 RIGHT, STERILE R, REF 12 000 0013, S&N 7500268, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
| Date | Apr 21, 2016 (initiated Mar 11, 2016) |
| Status | Terminated |
| Reason | The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery. |
| Root cause | Process control |
| Action | The firm, Smith & Nephew, issued an "URGENT FIELD SAFETY NOTICE: Medical Device Field Safety Corrective Action/Recall" letter dated 3/10/2016 to its local QA/RA personnel/customers in the affected countries by email on 03/11/2016. The letter described the product, problem and actions to be taken. The customers were instructed to locate and quarantine affected unused devices immediately; return quarantined product to your national Smith & Nephew agency/distributor; complete and return the Return Slip via fax to your national Smith & Nephew agency/distributor; and pass on this safety information |
| Quantity | 6 units |
| Distribution | International Distribution only in countries of: Germany and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072858 | TC-PLUS PRIMARY KNEE SYSTEM Smith & Nephew, Inc., Nov 20, 2007 |