Recall Z-2278-2013 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Synthes USA HQ, Inc.
Synthes 3.5 MM LCP(R) Distal Humerus System The Synthes 3.5 MM LCP Distal Humerus System is intended for fixation of fractures of the distal humerus, olecranon, and ulna in adults and adolescents (12-21) in which the growth plates have fused. Specifically, distal humerus plates are indicated for intra-articular fractures, comminuted supracondylar fractures, osteotomies, malunions and non-unions o
| Date | Sep 25, 2013 (initiated Mar 8, 2013) |
| Status | Terminated |
| Reason | Recall is being initiated due to the part being mislabeled (Part Number 241.267 was mislabeled with Part Number 241.276). |
| Root cause | Labeling mix-ups |
| Action | Synthes sent an Urgent Notice Medical Device Recall letter dated March 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 obtain a Return Authorization Number, complete the Verification Section at the end of the letter by the checking the appropriate box indicating affected product located. Return the Verification Form with the product to: Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132. Customers with questions were instructed to call 610-719-5450 or email Fieldacti |
| Quantity | 2 |
| Distribution | Nationwide Distribution including CA,and VA. . |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033995 | 3.5 MM LCP DISTAL HUMERUS SYSTEM Synthes (Usa), Mar 1, 2004 |