Recall Z-0309-2011 ยท HRS Plate, Fixation, Bone
Synthes USA (HQ), Inc.
3.5mm LCP Periarticular Proximal Humerus Plates Indicated for fractures and fracture dislocations, osteotomies, and nonunions of the proximal humerus, particularly for patients with osteopenic bone
| Date | Nov 2, 2010 (initiated Sep 16, 2010) |
| Status | Terminated |
| Reason | screw can pass through plate hole |
| Root cause | Nonconforming Material/Component |
| Action | Synthes (USA) notified all Synthes Trauma Hospital accounts of record of this recall via an Urgent Medical Device Recall letter dated September 27, 2010. The notification included instructions for hospital accounts to immediately cease use of the product, examine inventory, remove the 3.5 mm LCP Periarticular Proximal Humerus Plates from their shelves and complete and return the attached Verification Section form via mail: Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132; fax: 610-215-9005 or Scan/email: FieldAction@synthes.com. If they have any of the identified devices, they |
| Quantity | 2849 units |
| Distribution | Worldwide distribution: USA and countries including: Bermuda, Korea, Italy, Japan, Georgia, Qatar and Turkey |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082625 | SYNTHES (USA) 3.5MM LCP PERIARTICULAR PROXIMAL HUMERUS PLATES Synthes (Usa), Dec 17, 2008 |