Z-0483-2014Class II

Stryker Orthopaedics Cancellous Bone Screw Howmedica Osteonics Corp. Stryker France Both the 6.4 mm diameter...

Name: Z-0483-2014 Stryker Orthopaedics Cancellous Bone Screw Howmedica Osteonics Corp. Stryker France Both the 6.4 mm diameter...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2013-10-01
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2013-10-01 / Terminated / root cause: labeling and UDI

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Stryker Orthopaedics Cancellous Bone Screw Howmedica Osteonics Corp. Stryker France Both the 6.4 mm diameter, 25mm length, Cancellous Bone Screws (Cat no... on 2013-10-01. FDA classified it as Class II and gives the reason as "Stryker received a report from the field indicating that a 5.5 mm Cancellous Bone Screw 40 mm was identified in packaging associated with a 6.5 mm Cancellous Bone Screw 25 mm". 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-0483-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-01
Posted: 2013-12-11
Terminated: 2015-07-15
Recalling firm: Howmedica Osteonics Corp
Product: Stryker Orthopaedics Cancellous Bone Screw Howmedica Osteonics Corp. Stryker France Both the 6.4 mm diameter, 25mm length, Cancellous Bone Screws (Cat no 2030-6525-1) and the 5.5mm diameter, 40 mm length Cancellous Bone Screws (Cat no 2029-5540-1) are cleared for use in Total Hip Arthroplasty (THA), when implanting Stryker's Hemispherical Cluster Hole Acetabular Shell Systems and Total Knee Arthroplasty (TKA) when implanting Stryker's Series 7000 Standard Tibial Tray systems. The use of bone screws, during both THA and TKA are intended as supplemental fixation.
Product code: HWC Screw, Fixation, Bone
Reason for recall: Stryker received a report from the field indicating that a 5.5 mm Cancellous Bone Screw 40 mm was identified in packaging associated with a 6.5 mm Cancellous Bone Screw 25 mm.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Stryker sent notification letters/accountability forms via Fed Ex on October 1, 2013, with return receipt. to branches/agencies and hospital risk management, chief of orthopedics and surgeons. Domestic branch locations were notified by e-mail on 9/16/2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to fax the Product Recall Acknowledgement Form to 855-251-3635, return the affected product to the attention of Regulatory Compliance, Stryker Orthopaedics, 325 Corporate Drive, Mahwah, New Jersey, 07430. Customers were instructed to attach the fluorescent organge PRODUCT REMEDIATION sticker to their return, indicating the Produc Remediation # RA 2013-145. Mark the outer box with the words "Product Recall." Customers with questions were instructed to call 201-972-2100. For questions regarding this recall call 201-831-5000.
Quantity in commerce: Catalog Number 2030-6525-1- 4 units; Catalog No: 2029-5540-1-7 units
Distribution: Nationwide Distribution
Product codes and lots: 1) 6.5 mm Cancellous Bone Screw 25mm Catalog No: 2030-6525-1 Lot code MMLNLA 2) 5.5 Cancellous Bone Screw 40 mm Catalog No: 2029-5540-1 Lot Code MMLMJ1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0483-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0483-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-18	2013-12-11

Product code HWC

K894124Class IIOmnifit Self Tapping Cancellous Bone ScrewsOsteonics Corp. / cleared 1989-09-11

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)