Recall Z-0409-2014 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Synthes USA HQ, Inc.
Synthes 4.5 mm LCP Curved Condylar Plate Intended for buttressing multifragmentary distal femur fractures.
| Date | Nov 27, 2013 (initiated Jul 30, 2013) |
| Status | Terminated |
| Reason | The Synthes 4.5 mm LCP Curved Condylar Plate was recalled because a Straight Condylar Plate is etched with a Curved Condylar Plate part number. |
| Root cause | Process control |
| Action | Synthes sent an Urgent Notice: Medical Device Notification letter dated October 8, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to returny any of the affect devices, call Synthes at 1-800-479-6329 to obtain a Return Authorization Number, complete the Verification Section indicating the affected product has been located, also indicate the number of devices found and note the Return Authorization Number. Return the Verification Form to: Credit/Returns Synthes 1101 Synthes Avenue Monumen |
| Quantity | 13 |
| Distribution | Worldwide Distribution - USA including ID, FL, TN, NY, LA and Internationally to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041911 | SYNTHES (USA) LCP CURVED PLATES Synthes (Usa), Sep 8, 2004 |