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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
Related recalls
Same manufacturer · Stryker Howmedica Osteonics Corp.
See all →- HighStryker Recalls Hoffmann LRF Safety Clips Due to Loosening Risk
FDA (Devices) · 2017-05-31
- SevereStryker Recalls Reunion TSA Peg Alignment Sound Due to Breakage
FDA (Devices) · 2017-01-18
- ModerateStryker Recalls Kirschner Wires Due to Potential Sterile Pouch Seal Failure
FDA (Devices) · 2016-12-28
- SevereStryker Recalls LFIT Anatomic V40 Femoral Heads Due to Taper Lock Failure
FDA (Devices) · 2016-11-16
- HighStryker Orthopaedics Recalls Universal Acetabular Cup Positioner/Impactor
FDA (Devices) · 2016-10-19
Same hazard · screw failure
See all →- HighHead fixation devices recalled because a torque screw may crack or separate
FDA (Devices) · 2026-01-14
- HighOrthopedic Fixation Plates Recalled for Screw Locking Failure During Surgery
FDA (Devices) · 2025-03-05
- HighA.L.P.S. mvX Fibula Plate Recall: Locking Screw Malfunction During Surgery
FDA (Devices) · 2025-03-05
- HighMEDLINE UNITE Foot and Ankle Screw Recall: Intra-Operative Failure
FDA (Devices) · 2023-02-08
- HighMedline UNITE Foot & Ankle Screw Recalled for Intra-Operative Failure
FDA (Devices) · 2023-02-08
Similar recalls
- HighStryker Restoration Anatomic Shell Recalled Due to Packaging Defect
FDA (Devices) · 2020-05-27
- ModerateSynthes 5.0mm Variable Locking Screw Recalled for Incorrect Package Insert
FDA (Devices) · 2014-03-12
- ModerateStryker Restoration Anatomic Shell Recalled for Packaging Defect
FDA (Devices) · 2020-05-27
- ModerateStryker Restoration Anatomic Shell Recall Due to Packaging Defect
FDA (Devices) · 2020-05-27
- HighBiomet Recalls HipLOC Hip Fracture Fixation System Plates Due to Fit Issues
FDA (Devices) · 2018-10-03
- HighOrthofix Recalls Non-Locking Screws Due to Failure to Engage Plates
FDA (Devices) · 2018-06-13