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Urgent Enforcement Amended Final

Hoffmann3 Pin Chucks Coating Defect Type II Recall Affects Five Lots

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Summary

Stryker GmbH has issued a Type II Health Canada recall for Chuck For Pins Hoffmann3 Universal For Ø4/5/6mm (model 49229050) due to inhomogeneous coating with out-of-specification coating thickness and colour, discovered via product complaint. Five lots are affected: AR4000, AN4261, AU0794, AP3761, and 1544AB. Healthcare providers and facilities that hold these devices should contact the manufacturer directly for further information and guidance.

“Stryker confirmed that certain lots of Hoffman 3 Universal Pin Chucks contained inhomogeneous coating with out-of-specification coating thickness and color.”

Published by Health Canada on recalls-rappels.canada.ca . Detected, standardized, and enriched by GovPing. Review our methodology and editorial standards .

About this source

Health Canada operates a single recalls and safety alerts portal covering food, drugs, medical devices, consumer products, vehicles, and cosmetics. Roughly 100 alerts a month, with each entry tagged by hazard type, affected lots, distributor, and recommended consumer action. The portal is bilingual and aligns closely with FDA recalls in scope, so a Health Canada alert often signals a US recall is coming or has just landed. Watch this if you sell into Canada, run cross-border product compliance, or trade pharma equities exposed to recall events. Recent examples: Stryker Variax 2 locking screws pulled non-sterile, a Baxter head positioning adapter Type I recall, an Alecensaro hypertriglyceridemia and pancreatitis safety signal.

What changed

Health Canada has classified a Type II recall for Stryker GmbH's Chuck For Pins Hoffmann3 Universal For Ø4/5/6mm (model 49229050) after the firm confirmed that certain lots contained inhomogeneous coating with out-of-specification coating thickness and colour — a nonconformance identified through product complaints. Five lots are named in the recall: AR4000, AN4261, AU0794, AP3761, and 1544AB. The recall applies to all healthcare facilities and providers that have received or hold these products. Affected parties should contact Stryker directly for further information, as no specific disposal or return instructions are provided in the recall notice beyond manufacturer outreach.

This recall creates a product safety obligation for healthcare providers to identify and segregate the affected lots in their inventory. Although no stop-use or mandatory return instruction is stated, facilities should proactively confirm whether affected lots are in use or in stock and follow Stryker's guidance to mitigate risks associated with out-of-specification coating on pin chuck devices used in orthopaedic procedures.

What to do next

  1. Contact the manufacturer if you require additional information.

Archived snapshot

Apr 24, 2026

GovPing 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

Chuck For Pins Hoffmann3 Universal For Ø4/5/6mm

Brand(s)

Stryker Gmbh

Last updated

2026-04-23

Summary

Product Chuck For Pins Hoffmann3 Universal For Ø4/5/6mm 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
Chuck For Pins Hoffmann3 Universal For Ø4/5/6mm AR4000 49229050
Chuck For Pins Hoffmann3 Universal For Ø4/5/6mm AN4261 49229050
Chuck For Pins Hoffmann3 Universal For Ø4/5/6mm AU0794 49229050
Chuck For Pins Hoffmann3 Universal For Ø4/5/6mm AP3761 49229050
Chuck For Pins Hoffmann3 Universal For Ø4/5/6mm 1544AB 49229050

Issue

Stryker confirmed that certain lots of Hoffman 3 Universal Pin Chucks contained inhomogeneous coating with out-of-specification coating thickness and color. This nonconformance was discovered via product complaint.

Additional information

Details

Original published date:

2026-04-23

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

2026-04-13

Identification number RA-81916

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Last updated

Classification

Agency
Health Canada
Filed
April 23rd, 2026
Instrument
Enforcement
Branch
Executive
Legal weight
Binding
Stage
Final
Change scope
Substantive

Who this affects

Applies to
Healthcare providers Medical device makers
Industry sector
3345 Medical Device Manufacturing
Activity scope
Medical device recall Product safety response Quality notification
Geographic scope
Canada CA

Taxonomy

Primary area
Medical Devices
Operational domain
Clinical Operations
Compliance frameworks
GxP
Topics
Healthcare Product Safety

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