Trabecular Metal Tibial Augment Block (2019-02-07)

Starting date:

February 7, 2019

Posting date:

March 1, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-69176

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  Reason
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  Affected products

Affected Products

Trabecular Metal Tibial Augment Block

Reason

An investigation determined that potential co-mingling, resulting in the product in the box potentially not matching the product on the label.

The package says NexGen Complete Knee Solution Trabecular Metal Tibial Half Block Augment Right Lateral/Left Medial w/screws size 4 5mm thickness (PN: 00-5448-004-26) on the label however the product inside is NexGen Complete Knee Solution Trabecular Metal Tibial Half Block Augment Left Lateral/Right Medial w/screws size 4 5mm thickness (PN: 00-5448-004-36).

Affected products