Zimmer Trabecular Metal Reverse Shoulder System Instrumentation Liner Impactor

Starting date:

July 19, 2012

Posting date:

September 3, 2012

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-23807

• Reason
• Affected products

Recalled Products

1. Zimmer Trabecular metal Reverse Shoulder System Instrumentation Liner Impactor 40mm
2. Zimmer Trabecular Metal Reverse Shoulder System Instrumentation Liner Impactor 40mm 65 degree Neck Angle
3. Zimmer Trabecular Metal Reverse Shoulder System Instrumentation Liner Impactor 36mm
4. Zimmer Trabecular Metal Reverse Shoulder System Instrumentation Liner Impactor 36mm 65 degree Neck Angle

Reason

Lot specific recall due to reports of alignment peg fractures occurring in approximately 0.4% of surgeries. The recalled lots were manufactured from 455 stainless steel, which is the material that all of the reported fractured instruments were manufactured from. Due to the notch sensitivity of the 455 stainless steel, the peg on the Impactor manufactured with this material has a propensity for fracture. The remainder of lots that are not affected by this recall were made with 13-8 stainless steel.

Affected products