Comprehensive Reverse Shoulder Glenosphere Mini Baseplate… recallZ-1208-2015 · Biomet, Inc. · initiated Jan 7, 2015
Class II Terminated All recalls posted in February 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Biomet, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The taper adaptor is missing from the packaging, which may result in a delay in surgery greater than 30 minutes.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-1208-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jan 7, 2015
- Posted by the FDA
- Feb 24, 2015
- Recalling firm
- Biomet, Inc.
- Quantity
- 11- 6 consumed, 5 with distributors
- Product code
- KWS
- FDA submissions
- K120121
- Distribution
- Domestic: AL, FL, NY, TX Foreign: None
Product description
Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adaptor, Part Number: 010000589 Lot: 527400
Code information (models, lots, serial numbers)
Part Number: 010000589 Lot: 527400
Other devices under the same FDA submission
10 devices cleared under K120121 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Comprehensive Reverse Shoulder 010000589Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall142 reports
- Comprehensive® Instrumentation 110029136Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED16 reports
- Comprehensive Shoulder System 118000Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED15 reports
- COMPREHENSIVE INSTRUMENTATION 110029136Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED15 reports
- Comprehensive Reverse Shoulder 115330Biomet Orthopedics, LLC · shoulder prosthesis, reverse configuration13 reports
- COMPREHENSIVE 405809Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED4 reports
- COMPREHENSIVE 405807Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED4 reports
- Comprehensive Reverse Shoulder 115331Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- COMPREHENSIVE® INSTRUMENTATION 110025762Biomet Orthopedics, LLC · shoulder prosthesis, reverse configuration1 report
- Comprehensive® Reverse Shoulder Instrument 405809Biomet Orthopedics, LLC · shoulder prosthesis, reverse configuration1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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