Superior Approach Resection Guide Assembly. Indicated for primary, fracture, or revision total shoulder replacement for the relief of pain.
Reported: June 26, 2013 Initiated: May 15, 2013 #Z-1548-2013
Product Description
Superior Approach Resection Guide Assembly. Indicated for primary, fracture, or revision total shoulder replacement for the relief of pain.
Reason for Recall
Biomet has initiated this action following an investigation which identified that the slot on the resection guide is offset in the wrong direction. When the slot on the resection guide is offset in the wrong direction, the Steinman pin that is intended to hold the guide into place may not come into contact with the bone.
Details
- Recalling Firm
- Biomet, Inc.
- Units Affected
- 17
- Distribution
- Worldwide Distribution-USA (nationwide) including the states of UT, TX, AL, KY, and WI, and the countries of Australia, The Netherlands, Korea, and Canada.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
Superior Approach Resection Guide Assembly. Indicated for primary, fracture, or revision total shoulder replacement for the relief of pain.. Recalled by Biomet, Inc.. Units affected: 17.
Why was this product recalled? ▼
Biomet has initiated this action following an investigation which identified that the slot on the resection guide is offset in the wrong direction. When the slot on the resection guide is offset in the wrong direction, the Steinman pin that is intended to hold the guide into place may not come into contact with the bone.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 26, 2013. Severity: Moderate. Recall number: Z-1548-2013.
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