Z-2135-2008

Smooth or threaded metallic bone fixation fastener. 3.5mm x 14.0 mm Locking Cortical Screw. Product labeled...

Name: Z-2135-2008 Smooth or threaded metallic bone fixation fastener. 3.5mm x 14.0 mm Locking Cortical Screw. Product labeled...
Creator: Acumed LLC
Published: 2007-07-09
License: https://open.fda.gov/license/

Acumed LLC / initiated 2007-07-09 / Terminated / root cause: packaging

FDA source

Acumed LLC began a recall of Smooth or threaded metallic bone fixation fastener. 3.5mm x 14.0 mm Locking Cortical Screw. Product labeled in 3.5mm x 14.0 mm Locking Cortical Screw. Product... on 2007-07-09. The reason FDA records is "Product mislabeled. The inner sticky labels for the patient identified the product incorrectly as a Cortical screw (non-locking). The product package was labeled correctly". 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-2135-2008
Status: Terminated
Initiated: 2007-07-09
Posted: 2008-09-11
Terminated: 2010-02-03
Recalling firm: Acumed LLC
Product: Smooth or threaded metallic bone fixation fastener. 3.5mm x 14.0 mm Locking Cortical Screw. Product labeled in 3.5mm x 14.0 mm Locking Cortical Screw. Product labeled in part, "Congruent Plate System... Size: 3.5mm x 14.0 mm Locking Cortical Screw... REF COL-3140-S LOT W46772... Acumed 5885 NW Cornelius Pass Road Hilsboro, OR ". Product is used as an orthopedic implant.
Product code: HWC Screw, Fixation, Bone
Reason for recall: Product mislabeled. The inner sticky labels for the patient identified the product incorrectly as a Cortical screw (non-locking). The product package was labeled correctly.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: The firm issued a Product Removal notification on 8-9-2007. The notification was reportedly sent by either FAX or e-mail. The firm notified consignees of the issue and gave the consignees the choice of returning the screws. The notification did not include any instructions for a sub-recall. If you have any questions contact Jason Gozdecki at 1-888-627-9957.
Quantity in commerce: 400 screws
Distribution: Class III Recall - Worldwide Distribution --- USA including countries of UK and Japan.
Product codes and lots: Part number: COL-3140-S; Work order number/Lot: W46772 (W=work order, ###=sequential number); Expiration date: 2012-02 (Year/Month)

Product code HWC

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)