Recall Z-1548-2013— Biomet, Inc.
Class II · Terminated
Class II FDA medical device recall by Biomet, Inc., initiated 2013-05-15, terminated 2014-06-09. It names one FDA 510(k) clearance: K080642. Product: Superior Approach Resection Guide Assembly. Indicated for primary, fracture, or revision total shoulder replacement for the relief of pain.. Reason: 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..
- Recalling firm
- Biomet, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-05-15
- Terminated
- 2014-06-09
- Firm location
- Warsaw, IN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.