Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adaptor, Part Number: 010000589 Lot: 527400
This recall has been terminated (originally issued February 24, 2015).
- Company
- Biomet, Inc.
- Recall Initiated
- January 7, 2015
- Posted
- February 24, 2015
- Terminated
- October 22, 2015
- Recall Number
- Z-1208-2015
- Quantity
- 11- 6 consumed, 5 with distributors
- Firm Location
- Warsaw, IN
- Official Source
- View on FDA website ↗
Reason for Recall
The taper adaptor is missing from the packaging, which may result in a delay in surgery greater than 30 minutes.
Distribution
Domestic: AL, FL, NY, TX Foreign: None
Lot / Code Info
Part Number: 010000589 Lot: 527400
Root Cause
Process control
Action Taken
Biomet issued written notices on 1/7/2015, Requested completion and submission of response/effectiveness forms for Product Part Number: 01 0000589 Product Description: Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adapter, Expiration October 2024. Questions related to this notice should be directed to Audrey Daenzer, Field Action Specialist (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.
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