Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adaptor, Part Number: 010000589 Lot: 527400
FDA device recall Z-1208-2015 · posted 2015-02-24 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- The taper adaptor is missing from the packaging, which may result in a delay in surgery greater than 30 minutes.
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- KWS
- Quantity affected
- 11- 6 consumed, 5 with distributors
- Distribution
- Domestic: AL, FL, NY, TX Foreign: None
- Date initiated
- 2015-01-07
- Date posted
- 2015-02-24
- Date terminated
- 2015-10-22
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COMPREHENSIVE REVERSE SHOULDER-MINI BASEPLATE (K120121) | Biomet, Inc. | 2012-02-16 |