Modular Shoulder Body Assembly, Left (SH-1540L-S) and Modular Shoulder Body Assembly, Right (SH-1540R-S). Product labele
FDA device recall Z-0447-2009 · posted 2008-12-11 · Terminated
Recall details
- Recalling firm
- Acumed LLC
- Reason for recall
- 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.
- Action taken
- 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
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- HSD
- Quantity affected
- 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.
- Date initiated
- 2008-05-13
- Date posted
- 2008-12-11
- Date terminated
- 2010-05-13
- Location
- Hillsboro, OR
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACUMED MODULAR SHOULDER SYSTEM (K992525) | Acu Med, Inc. | 2000-02-04 |