Trabecular Metal Primary Hip Prosthesis Femoral Stem 128mm Stem Length Standard and Extended Offset (2018-01-10)

Starting date:

January 10, 2018

Posting date:

January 29, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-65784

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  Reason
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  Affected products

Affected products

1. Trabecular Metal Primary Hip Prosthesis Femoral Stem 128mm Stem Length Standard Offset
2. Trabecular Metal Primary Hip Prosthesis Femoral Stem 128mm Stem Length Extended Offset

Reason

Zimmer Biomet is conducting a medical device recall for two lots of Trabecular Metal Stems (listed). A complaint was received indicating that a "13mm extended" stem was in a box labelled as a "13mm standard" stem. The investigation determined that the lots were commingled, hence both the lots are being recalled from the field.

Affected products