CLASS II Device recall · Reported 27 Apr 2016 · FDA Enforcement Report
VariAx Compression Plating System recalled
Stryker Howmedica Osteonics is recalling VariAx Compression Plating System, distributed nationwide in the US. The recall was initiated on 10 Oct 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1507-2016
- FDA event ID
- 73505
- Recalling firm
- Stryker Howmedica Osteonics, Mahwah, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Oct 2013
- FDA classified
- 18 Apr 2016
- Reported
- 27 Apr 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 10 Oct 2013 | Recall initiated by company | |
| 18 Apr 2016 | Classified by FDA | +921 days |
| 27 Apr 2016 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
VariAx Compression Plating System
Where it was distributed
Nationwide Distribution
Questions about this recall
Why was it recalled?
Stryker received two reports indicating that during screw insertion under a high lateral angle a bone screw went through a oblong hole.
Which lots are affected?
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
Where was it sold?
Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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