Z-1548-2013 Class II Terminated
FDA device recall Z-1548-2013 was initiated by Biomet, Inc. on May 15, 2013 and is designated Class II. 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 recall status is terminated (terminated Jun 9, 2014). Affected quantity: 17.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 26, 2013
- Initiation Date
- May 15, 2013
- Termination Date
- Jun 9, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17
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.
Distribution Pattern
Worldwide Distribution-USA (nationwide) including the states of UT, TX, AL, KY, and WI, and the countries of Australia, The Netherlands, Korea, and Canada.
Code Information
Catalog number: 010001814 and lot numbers: 318520 and 644720.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1548-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026