Spinal Rod Cutter (2020-11-25)

Starting date:

November 25, 2020

Posting date:

December 4, 2020

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-74473

Last updated:
2020-12-03

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  Reason
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  Affected products

Affected Products

Spinal Rod Cutter

Reason

Zimmer Biomet is conducting a medical device recall for all lots of 00-3925-002-00 Spinal Rod Cutter maximum pin diameter 1/4 inch (6.4M) due to the potential for fracture during use. The cutter is primarily used in spine procedures to cut stainless steel rods. If the pin cutter were to fracture during use, it would be easily recognized. The highest severity event may result if the cutters were to fracture intra-operatively in an internal fixation procedure and a fragment creates a puncture wound that resulted in permanent impairment of a body function or damage to a body structure.

Affected products