Z-2140-2008

Osteo-Clage Cable System Package Assembly (01-0001-S). Product labeled in part, "2.0mm x 850 mm CoCr Cable /...

Name: Z-2140-2008 Osteo-Clage Cable System Package Assembly (01-0001-S). Product labeled in part, "2.0mm x 850 mm CoCr Cable /...
Creator: Acumed LLC
Published: 2008-03-28
License: https://open.fda.gov/license/

Acumed LLC / initiated 2008-03-28 / Terminated / root cause: manufacturing process

FDA source

Acumed LLC began a recall of 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... on 2008-03-28. The reason FDA records is "Cables of incorrect diameter were used in product assembly, resulting in the sleeve not being able to bind to the cable after crimping". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2140-2008
Status: Terminated
Initiated: 2008-03-28
Posted: 2008-08-22
Terminated: 2010-02-03
Recalling firm: Acumed LLC
Product: 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 ".
Product code: JDQ Cerclage, Fixation
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.
Root cause tag: manufacturing process
FDA root cause: Employee error
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.
Quantity in commerce: 50 units
Distribution: Nationwide Distribution --- including states of AR, CA, PA, GA, KS, MO, and TN.
Product codes and lots: Work order number/Lot: W59192 (W=work order, ###=sequential number); Expiration date: 2015-01 (Year/Month)

Product code JDQ

K921480Class IIOsteo-Clage(tm) Cerciage Cable SystemAcu-Med, Inc. / cleared 1992-06-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)