Recall Z-0362-2008 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Plus Orthopedics USA
VKS Tibial Trial, Right/Left, Prep Guide; Model Number: 1214331, 1214332, 1214333, 1214334, 1214335: ( Model Number: 1214331 VKS Tibial Prep Guide, Right/Left, Size 1, Lot Code EM. 1 and EM.6; 1214332 VKS Tibial Prep Guide, Right/Left, Size 2 Lot Code EM.l and EM.6, 1214333 VKS Tibial Prep Guide, Right/Left, Size 3 Lot Code EM.1; 1214334 VKS Tibial Prep Guide, Right/Left, Size 4 Lot Code EM.5; 12
| Date | Dec 8, 2007 (initiated Nov 27, 2006) |
| Status | Terminated |
| Reason | The VKS "Tibial Trial" was found to have an incorrect fixation pin hole diameter. |
| Root cause | Process control |
| Action | The initial depth of the withdrawal action taken November 2006 was to the distributor (agent) level. On 11/27/2006 Plus Orthopedics USA contacted individual agent sites showing inventory of the affected article numbers on hand and requested that those items be returned to Plus USA. Agents were notified by telephone to check their inventory and return any affected units. A telephone script was used. |
| Quantity | 19 |
| Distribution | Nationwide to : AZ, CA, CO, FL, ID, NE, NY, SC, TX, UT, VA, and WA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.