Z-2131-2008

Locking Clavicle Plate, 9 Holes, J-Plate Left. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road...

Name: Z-2131-2008 Locking Clavicle Plate, 9 Holes, J-Plate Left. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road...
Creator: Acumed LLC
Published: 2008-02-14
License: https://open.fda.gov/license/

Acumed LLC / initiated 2008-02-14 / Terminated / root cause: packaging

FDA source

Acumed LLC began a recall of Locking Clavicle Plate, 9 Holes, J-Plate Left. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Locking Clavicle... on 2008-02-14. The reason FDA records is "Product sterility may be compromised". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2131-2008
Status: Terminated
Initiated: 2008-02-14
Posted: 2008-09-20
Terminated: 2010-02-03
Recalling firm: Acumed LLC
Product: Locking Clavicle Plate, 9 Holes, J-Plate Left. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Locking Clavicle Plate, 9 Holes, J-Plate Left... REF PL-CL9JL-S LOT W57690 ".
Product code: HWC Screw, Fixation, Bone
Reason for recall: Product sterility may be compromised.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: The firm issued four separate Urgent Notification: Product Removal were issued by the firm on 2-14-2008, 2-20-2008, 2-26-2008, and 3-25-2008 for the issue of poorly sealed sterile pouches. The notifications were reportedly sent by either FAX or e-mail. The firm explained the issue and requested customers to return the specified products. On 7/16/08, the firm issued a second recall notification to their customers. This letter informed the customer of the recall, listed the products affected, stated the reason for the recall, tells customers, "return existing inventories of the recalled products to Acumed... If you further distributed this product, please notify those customers/consignees of this recall. This recall is to be extended to the user level." The letter includes an effectiveness form to be filled out by the customer and returned to Acumed.
Quantity in commerce: 10 pcs
Distribution: Worldwide Distribution ---- USA including states of WA, NE, NC, UT, FL, CA, OR, TX, NY, IL, OH, MT, and Puerto Rico, and countries of United Kingdom, Australia, and Greece.
Product codes and lots: Work order number/Lot: W57690 (W=work order, ###=sequential number); Expiration date: 2014-11 (Year/Month)

Product code HWC

K012655Class IICongruent Bone Plate SystemAcu Med, Inc. / cleared 2001-11-07

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

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)