Recall Z-1199-2017 ยท HRS Plate, Fixation, Bone
Acumed LLC
6-hole Pubic Symphysis plate (PN 70-0451). The pelvic bone plates for the pelvic ring are a series of plates with varying lengths that function as internal fixation devices for fractures, fusions and osteotomies of the pelvic ring. The plates are strategically pre-contoured where beneficial to the application, and they are secured to the bone with 3.5mm non-locking screws. The Acumed pelvic ring
| Date | Feb 14, 2017 (initiated Jan 19, 2017) |
| Status | Terminated |
| Reason | The 6-hole Pubic Symphysis plate (PN 70-0451) is specified to be made of Commercially Pure Titanium (ASTM F67 - CP Grade 4). However, batch 383813 was manufactured out of Titanium Alloy (Ti-6Al- 4V ELI per ASTM F135 Ti alloy) and was distributed. |
| Root cause | Mixed-up of materials/components |
| Action | Acumed sent an Urgent Medical Device Recall letter dated January 16, 2017, to all affected customers on January 19, 2017. Consignees were instructed to follow special instructions and send survey to RecallNotification@acumed.net. Domestic customers with questions or need to return products to Acumed, please contact Acumed Agent Inventory via email AgentInventory@acumed.net to obtain a Return Material Authorization (RMA) number or contact your agent directly. International customers with questions or need to return products to Acumed, please contact Acumed Business Service via email at Busi |
| Quantity | 15 units |
| Distribution | Worldwide Distribution - Costa Rica, Malaysia, Mexico, South Africa, and Spain |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122538 | ACUMED PELVIC BONE PLATE SYSTEM Acumed, LLC, Nov 19, 2012 |