Z-2146-2012Class II

djo surgical Screw 6.5 mm, Sz 25mm, low profile. Product is intended for the fixation of the acetabular shell...

Name: Z-2146-2012 djo surgical Screw 6.5 mm, Sz 25mm, low profile. Product is intended for the fixation of the acetabular shell...
Creator: Encore Medical, Lp
Published: 2012-07-16
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2012-07-16 / Terminated / root cause: packaging

FDA source

Encore Medical, Lp began a recall of djo surgical Screw 6.5 mm, Sz 25mm, low profile. Product is intended for the fixation of the acetabular shell or fracture repair on 2012-07-16. FDA classified it as Class II and gives the reason as "One lot of the 010-55-030, 6.5 mm Cancellous Bone Screw was recalled because a product complaint identified a mislabeling of the device. Although the package label indicates Size 30mm, the screw dimension is actually...". 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-2146-2012
Classification: Class II
Status: Terminated
Initiated: 2012-07-16
Posted: 2012-08-06
Terminated: 2012-12-04
Recalling firm: Encore Medical, LP
Product: djo surgical Screw 6.5 mm, Sz 25mm, low profile. Product is intended for the fixation of the acetabular shell or fracture repair
Product code: HWC Screw, Fixation, Bone
Reason for recall: One lot of the 010-55-030, 6.5 mm Cancellous Bone Screw was recalled because a product complaint identified a mislabeling of the device. Although the package label indicates Size 30mm, the screw dimension is actually 25mm.
Root cause tag: packaging
FDA root cause: Packaging
Action: DJO Global sent an Urgent Field Safety Notice dated July 16, 2012, to all affected customers. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to forward the notice to all thoe who need to be aware within their organization or to any other organization where the potentially affected product was transferred, contact customers to place a replacement order and receive an RMA number, and return all affected devices using the RMA number. For questions customers should call 512-834-6255. For questions regarding this recall call 512-832-9500.
Quantity in commerce: 18 devices
Distribution: Nationwide Distribution including AR, CA, FL, ID, OK, PA, TX, and UT.
Product codes and lots: Lot 007A1037, Ref 010-55-25.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2146-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2146-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-15	2012-08-06

Product code HWC

K931665Class II6.5 Mm Cancellous Bone ScrewEncore Orthopedics, Inc. / cleared 1994-02-17

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)