Osteo-Clage Cable System Package Assembly (01-0001-S). Product labeled in part, "2.0mm x 850 mm CoCr Cable / Sleeve... REF 01-0001-S LOT W59192... Acumed 5885 NW Cornelius Pass Road Hilsboro, OR 97124-9432 ".
Hazard
Cables of incorrect diameter were used in product assembly, resulting in the sleeve not being able to bind to the cable after crimping.
What You Should Do
Remedy
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.
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Products
Osteo-Clage Cable System Package Assembly (01-0001-S). Product labeled in part, "2.0mm x 850 mm CoCr Cable / Sleeve... REF 01-0001-S LOT W59192... Acumed 5885 NW Cornelius Pass Road Hilsboro, OR 9712
- Brand
- Acumed LLC
- UPC
- Work order number/Lot: W59192 (W=work order, ###=sequential number); Expiration date: 2015-01 (Year/Month)
Units Affected
50 units