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
Recall
- Recall Number
- Z-0309-2011
- Event Number
- 56837
- Firm
- Synthes USA (HQ), Inc.
- FEI Number
- 3005180112
- Product Code
- HRS
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- September 16, 2010
- Posted
- November 2, 2010
- Terminated
- April 16, 2015
- Address
- 1302 Wrights Ln E, West Chester, PA, 19380-3417
Description
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
screw can pass through plate hole
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: [email protected]. If they have any of the identified devices, they were to call Synthes at 1-800-479-6329 to obtain Authorization number prior to completing Verification form. If you have any questions, please call 1-800-620-7025 x5403 or contact your Synthes Trauma Sales Consultant.
Worldwide distribution: USA and countries including: Bermuda, Korea, Italy, Japan, Georgia, Qatar and Turkey
2849 units