Stryker Recalls VariAx Compression Plating System Due to Screw Failure
Stryker Howmedica Osteonics Corp. is recalling 118 units of the VariAx Compression Plating System because bone screws may pass through oblong holes during insertion.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product where injury has not yet been reported, meeting the criteria for a High severity score.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling 118 units of the VariAx Compression Plating System. The recall is due to two reports indicating that during screw insertion under a high lateral angle, a bone screw went through an oblong hole.
The affected products are distributed nationwide and include 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, and 629570S.
Healthcare providers should stop using the affected devices and contact Stryker Howmedica Osteonics Corp. for instructions on how to return or replace the units.
The recalled product
- Product
- VariAx Compression Plating System
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Hazard
- Affected units
- 118
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- catalog numbers 629503S
- 629504S
- 629505S
- 629506S
- 629507S
- 629508S
- 629509S
- 629510S
- 629527S
- 629537S
- 629543S
- 629544S
- 629545S
- 629546S
- 629547S
- 629548S
- 629559S
- 629560S
- 629561S
- 629562S
Distribution
Distributed nationwide across the United States.
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