Recall Z-0447-2009 ยท HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Acumed LLC
Modular Shoulder Body Assembly, Left (SH-1540L-S) and Modular Shoulder Body Assembly, Right (SH-1540R-S). Product labeled in part, "Acumed 5885 NW Cornelius Pass Road Hillsboro, OR 97124-9432 "
| Date | Dec 11, 2008 (initiated May 13, 2008) |
| Status | Terminated |
| Reason | The packages for Modular Shoulder Body Assembly Left (SH-1540L-S) and Modular Shoulder Body Assembly Right (SH-1540R-S) may contain assemblies for the opposite side as indicated. |
| Root cause | Labeling mix-ups |
| Action | The firm issued a Urgent Notice: Device Recall on 5/13/08. The firm notified consignees of the issue and asked them to return the product to Acumed with the enclosed product recall effectiveness form for customers. For further information contact Acumed customer service at 1-888-627-9957 |
| Quantity | 20 units |
| Distribution | World-wide distribution including states of GA, MD, CA, MO, and AL, countries of United Kingdom, South Korea, South Africa, and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992525 | ACUMED MODULAR SHOULDER SYSTEM Acu Med, Inc., Feb 4, 2000 |