Z-0139-2013Class II

6.5mm Cancellous Bone Screw Intended to be used for the fixation of the acetabular shell or fracture repair

Name: Z-0139-2013 6.5mm Cancellous Bone Screw Intended to be used for the fixation of the acetabular shell or fracture repair
Creator: Encore Medical, Lp
Published: 2012-09-28
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2012-09-28 / Terminated / root cause: labeling and UDI

FDA source

Encore Medical, Lp began a recall of 6.5mm Cancellous Bone Screw Intended to be used for the fixation of the acetabular shell or fracture repair on 2012-09-28. FDA classified it as Class II and gives the reason as "A product complaint was received where a size 20 screw was labeled as size 30. After receipt, measurement of the screw determined it to be a size 25. Further investigation also determined that there were other screws...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0139-2013
Classification: Class II
Status: Terminated
Initiated: 2012-09-28
Posted: 2012-10-25
Terminated: 2013-01-25
Recalling firm: Encore Medical, LP
Product: 6.5mm Cancellous Bone Screw Intended to be used for the fixation of the acetabular shell or fracture repair.
Product code: HWC Screw, Fixation, Bone
Reason for recall: A product complaint was received where a size 20 screw was labeled as size 30. After receipt, measurement of the screw determined it to be a size 25. Further investigation also determined that there were other screws labeled as size 25, but a size 30 screw was inside of the package. It was thought that all of these screws were found in-house and were contained, but it was determined later that on
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Encore Medical sent a Urgent Field Safety Notice dated September 28, 2012, to all affected customers. This notice needs to be passed on all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Please contact Customer Service to place a replacement order and receive an RMA number. Return all affected devices using the RMA number. For further questions please call (512) 834-6255
Quantity in commerce: 1 unit
Distribution: Nationwide Distribution only to CA.
Product codes and lots: Model Number 10-55-025, Lot Number 006A1057.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0139-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0139-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-25

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)