Recall Z-0928-06 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Plus Orthopedics USA
Model Number: GNRADIOLUCENTGUIDE (Gliding Nail Radiolucent Guide), instrument set that contains one unit of each of the following instrument: 1130020-A: GNp Carbon Targeting Handle 1130021-A: GN Adapter Screw for Handle SW 10 1130022-A: GN Targeting Guide Carbon 125 1130023-A: GN Targeting Guide Carbon 135 1130060-A: GNp Drill Guide Locking No. 3 1133158-A: GN Centering Sleeve New Guide
| Date | Jun 2, 2006 (initiated Feb 22, 2006) |
| Status | Terminated |
| Reason | PLUS USA has been informed by PLUS AG that the accuracy of the instrument set may be affected in some cases. It is possible that in rare cases where patients have sclerotic (excessively hardened or firm) bone, that components may deform under application of force as the surgeon attempts to penetrate this bone with the instruments. |
| Root cause | Other |
| Action | There were a total of five (5) radiolucent guide instrument sets affected by the recall (imported to the U.S. between 1/23/2006 and 1/30/2006). The firm telephoned agents beginning February 22, 2006, requesting return of the devices. Returned Material Authorizations have been issued (March, 2006) for consigned inventory in the field with instructions given to remove and return affected units immediately. All returns to PLUS Orthopedics USA have been appropriately quarantined and segregated to prevent unintended use or shipment. |
| Quantity | 5 |
| Distribution | There were a total of five (5) radiolucent guide instrument sets affected by the recall (imported to the U.S. between 1/23/2006 and 1/30/2006). The 5 sets were distributed in the following states: 1) California, 2) Idaho, and 3) New York. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.