Osteo-Clage Cable System Package Assembly (01-0001-S). Product labeled in part, "2.0mm x 850 mm CoCr Cable / Sleeve... R
FDA device recall Z-2140-2008 · posted 2008-08-22 · Terminated
Recall details
- Recalling firm
- Acumed LLC
- Reason for recall
- Cables of incorrect diameter were used in product assembly, resulting in the sleeve not being able to bind to the cable after crimping.
- Action taken
- On 3/28/08, the firm sent an Urgent Notification letter to their consignees. The letter explained the issue and requested the customers return the product to Acumend. On 7/16/08, the firm sent a 2nd notification, via mail, to thier customers. The Urgent Notice: Device Recall 2nd Notification, advised customers of the recall, the hazard and requested customers to return existing product to Acumed.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- JDQ
- Quantity affected
- 50 units
- Distribution
- Nationwide Distribution --- including states of AR, CA, PA, GA, KS, MO, and TN.
- Date initiated
- 2008-03-28
- Date posted
- 2008-08-22
- Date terminated
- 2010-02-03
- 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 |
|---|---|---|
| OSTEO-CLAGE(TM) CERCIAGE CABLE SYSTEM (K921480) | Acu-Med, Inc. | 1992-06-26 |