Stryker IMN Locking Screw Recalled in Canada Over Mislabeling

Health Canada has issued a Type II medical device recall for a single lot of Stryker’s IMN Screws System Advanced Locking Screw after the manufacturer discovered that the product was mislabeled. The affected screw is actually 75mm in length, not the 57.5mm printed on its packaging, a mix-up that could lead to a surgeon selecting the wrong implant during an orthopaedic procedure.

The recall, published by Health Canada on September 10, 2026, was triggered after Stryker Gmbh received a product complaint and, as part of its standard quality review process, confirmed the labeling error. The company traced the issue to one specific lot of the T2 Alpha IMN advanced locking screw line.

What Products Are Being Recalled?

The recall covers the ‘IMN Screws System Advanced Locking Screw,’ manufactured by Stryker Gmbh. Only one lot is implicated in this action:

• Lot or serial number: K17FE5A
• Model or catalogue number: 2361-5057S

The product falls under Health Canada’s medical devices category, specifically orthopaedics, and is intended strictly for use by healthcare professionals rather than direct consumer purchase.

Why Was This Recall Issued?

According to Health Canada’s notice, Stryker confirmed that one lot of the T2 Alpha IMN advanced locking screw was ‘incorrectly labeled.’ The package identifies the screw as 57.5mm in length, but the actual component inside measures 75mm. In orthopaedic trauma surgery, where intramedullary nailing systems like the T2 Alpha rely on precisely sized locking screws to stabilize a fracture, using a screw that is nearly 18mm longer than intended could compromise fixation, damage surrounding bone or tissue, or require additional corrective steps during or after surgery.

Health Canada classifies this as a device compatibility issue, and the recall carries a Type II classification, meaning the mislabeling could cause temporary or medically reversible harm, or where the probability of serious harm is remote.

Who Is Affected?

This recall is directed at healthcare facilities and surgical staff who may have received or stocked the affected lot of the IMN Screws System Advanced Locking Screw. Because these are implantable surgical components used exclusively within clinical and hospital settings, ordinary consumers would not have purchased or handled this product directly. The audience for this alert is specifically listed as ‘Healthcare.’

The recall applies within Canada, where Stryker Gmbh’s products are distributed through hospital and surgical supply channels. Stryker Gmbh is headquartered at Bohnackerweg 1 in Selzach, Solothurn, Switzerland.

What Should You Do?

Healthcare providers and facilities that may have lot K17FE5A or model 2361-5057S in inventory should immediately check their surgical stock against these identifiers. Any units matching the recalled lot should be set aside and not used in surgical procedures until further guidance is received from the manufacturer.

Health Canada’s official instruction for this recall is direct: ‘Contact the manufacturer if you require additional information.’ Facilities with questions about affected inventory, replacement screws, or further steps should reach out to Stryker Gmbh directly through their regular supplier or regional representative channels.

Official Statement

Per Health Canada’s published notice, the issue stemmed from a product complaint that prompted Stryker’s internal quality process. Health Canada summarized the matter as follows: the T2 Alpha IMN advanced locking screw ‘is incorrectly labeled’ and ‘contains a 75mm length screw instead of 57.5mm.’

The recall was formally logged under identification number RA-82612, with an original recall date of September 1, 2026, and the notice was last updated on September 10, 2026. Health Canada continues to monitor medical device recalls of this kind under its ongoing device safety oversight program, and encourages healthcare professionals to report any related concerns or adverse events through its official reporting channels.