Z-1208-2015 Class II Terminated
FDA device recall Z-1208-2015 was initiated by Biomet, Inc. on Jan 7, 2015 and is designated Class II. Reason for recall: The taper adaptor is missing from the packaging, which may result in a delay in surgery greater than 30 minutes. The recall status is terminated (terminated Oct 22, 2015). Affected quantity: 11- 6 consumed, 5 with distributors.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 4, 2015
- Initiation Date
- Jan 7, 2015
- Termination Date
- Oct 22, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11- 6 consumed, 5 with distributors
Product Description
Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adaptor, Part Number: 010000589 Lot: 527400
Reason for Recall
The taper adaptor is missing from the packaging, which may result in a delay in surgery greater than 30 minutes.
Distribution Pattern
Domestic: AL, FL, NY, TX Foreign: None
Code Information
Part Number: 010000589 Lot: 527400
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1208-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026