FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: VariAx Compression Plating System
- Recall number
- Z-1507-2016
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- VariAx Compression Plating System
- Status
- Terminated
- Initiated
- 2013-10-10
- Posted
- 2016-04-18
- Terminated
- 2016-04-21
- Reason
- Stryker received two reports indicating that during screw insertion under a high lateral angle a bone screw went through a oblong hole.
- 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
- 118 units
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K130009"]
- PMA numbers
- not on file
- Product code
- HWC
- Firm FEI
- 3003070421
- Firm city
- Mahwah
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28