Recall Z-0138-2018 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 4F/3T, Alpha, Ref 208-04-41, Sterile, RX.
| Date | Sep 19, 2017 |
| Status | Terminated |
| Reason | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. |
| Root cause | Labeling design |
| Action | The recalling firm issued a letter dated 9/19/2017 via email to their customers. |
| Quantity | 527 devices |
| Distribution | Distribution was made to AL, FL, IN, ME, MN, NJ, NY, OH, OK, VA, and Puerto Rico. Foreign distribution was made to Argentina, Australia, Brazil, China, Colombia, France, India, Italy, Luxembourg, The Netherlands, Spain, Switzerland, Tunisia, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023186 | OPTETRAK TOTAL KNEE SYSTEM OFFSET TIBIAL TRAY Exactech, Inc., Oct 17, 2002 |