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 ".
FDA Recall Z-2140-2008 · Posted 2008-08-22
Recalling FirmAcumed LLC
Recall StatusTerminated
Product CodeJDQ
Date Initiated2008-03-28
Date Terminated2010-02-03
Product Quantity50 units
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.
Firm Action
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
Distribution Pattern
Nationwide Distribution --- including states of AR, CA, PA, GA, KS, MO, and TN.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.