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 ".
This recall has been terminated (originally issued August 22, 2008).
- Company
- Acumed Llc
- Recall Initiated
- March 28, 2008
- Posted
- August 22, 2008
- Terminated
- February 3, 2010
- Recall Number
- Z-2140-2008
- Quantity
- 50 units
- Firm Location
- Hillsboro, OR
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide Distribution --- including states of AR, CA, PA, GA, KS, MO, and TN.
Lot / Code Info
Work order number/Lot: W59192 (W=work order, ###=sequential number); Expiration date: 2015-01 (Year/Month)
Root Cause
Employee error
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.