Z-1507-2016Class II

VariAx Compression Plating System

Name: Z-1507-2016 VariAx Compression Plating System
Creator: Stryker Howmedica Osteonics Corp.
Published: 2013-10-10
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2013-10-10 / Terminated / root cause: design

FDA source

Stryker Howmedica Osteonics Corp. began a recall of VariAx Compression Plating System on 2013-10-10. FDA classified it as Class II and gives the reason as "Stryker received two reports indicating that during screw insertion under a high lateral angle a bone screw went through a oblong hole". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1507-2016
Classification: Class II
Status: Terminated
Initiated: 2013-10-10
Posted: 2016-04-18
Terminated: 2016-04-21
Recalling firm: Howmedica Osteonics Corp
Product: VariAx Compression Plating System
Product code: HWC Screw, Fixation, Bone
Reason for recall: Stryker received two reports indicating that during screw insertion under a high lateral angle a bone screw went through a oblong hole.
Root cause tag: design
FDA root cause: Device Design
Action: Stryker Orthopaedics sent notification letters/product accountability forms on October 10, 2013, via email. Customers are provided the product issue, hazards and risk mitigation along with actions needed. Customers should receive the affected products and complete the BRF and return to Stryker. Questions can be directed to Stryker. For further questions, please call (201) 831-5000.
Quantity in commerce: 118 units
Distribution: Nationwide Distribution
Product codes and lots: catalog numbers 629503S, 629504S, 629505S, 629506S, 629507S, 629508S, 629509S, 629510S, 629527S, 629537S, 629543S, 629544S, 629545S, 629546S, 629547S, 629548S, 629559S, 629560S, 629561S, 629562S, 629564S, 629566S, 629568S, 629570S

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1507-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1507-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-27	2016-04-18

Product code HWC

K130009Class IIVariax 2 Compression Plating SystemStryker Trauma AG / cleared 2013-03-22

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)