Stryker Variax 2 Locking Screw - Non-Sterile, Lot AM5253
Summary
Health Canada has issued a Type II medical device recall for Stryker Gmbh's Variax 2 Locking Screw - Non-Sterile, Lot AM5253 (model/catalogue number 657328). Stryker confirmed that one lot was manufactured without the hexalobular feature required for mating with the associated screwdriver, creating a device incompatibility issue. Healthcare providers who have this product in stock should contact the manufacturer for additional information and next steps.
“Stryker has confirmed that one lot of Variax® 2 Locking crews was manufactured without the hexalobular feature required for mating with the associated screwdriver.”
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What changed
Health Canada has issued a Type II medical device recall affecting Stryker Gmbh's Variax 2 Locking Screw - Non-Sterile, Lot AM5253 (model 657328). The recall was initiated after Stryker confirmed that the affected lot was manufactured without the hexalobular feature required for mating with the associated screwdriver, which prevents proper device use during surgical procedures.
Healthcare providers and facilities that have purchased or stocked this specific lot should immediately check their inventory and contact Stryker Gmbh directly for guidance on how to handle the affected product. Healthcare facilities performing orthopedic surgical procedures using Stryker Variax 2 systems should verify their supply chain records for Lot AM5253 and coordinate with Stryker regarding return or replacement options.
Archived snapshot
Apr 23, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Health product recall
Variax 2 Locking Screw - Non-Sterile
Brand(s)
Last updated
2026-04-22
Summary
Product Variax 2 Locking Screw - Non-Sterile Issue Medical devices - Performance What to do Contact the manufacturer if you require additional information.
Audience Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Variax 2 Locking Screw - Non-Sterile | AM5253 | 657328 |
Issue
Stryker has confirmed that one lot of Variax® 2 Locking crews was manufactured without the hexalobular feature required for mating with the associated screwdriver.
Additional information
Details
Original published date:
2026-04-22
Alert / recall type Health product recall Category Health products - Medical devices - Orthopaedics Companies Stryker Gmbh
Bohnackerweg 1, Selzach, Solothurn, Switzerland, 2545
Published by Health Canada Audience Healthcare Recall class Type II Recall date
2026-04-08
Identification number RA-81913
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