FDA Medical Device Recalls (openFDA)
Biomet, Inc.: Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adaptor, Part Number: 010000589 Lot: 527400
- Recall number
- Z-1208-2015
- Recalling firm
- Biomet, Inc.
- Product
- Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adaptor, Part Number: 010000589 Lot: 527400
- Status
- Terminated
- Initiated
- 2015-01-07
- Posted
- 2015-02-24
- Terminated
- 2015-10-22
- Reason
- The taper adaptor is missing from the packaging, which may result in a delay in surgery greater than 30 minutes.
- Root cause
- Process control
- Action
- 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.
- Quantity
- 11- 6 consumed, 5 with distributors
- Distribution
- Domestic: AL, FL, NY, TX Foreign: None
- Lot, serial or model codes
- Part Number: 010000589 Lot: 527400
- 510(k) numbers
- ["K120121"]
- PMA numbers
- not on file
- Product code
- KWS
- Firm FEI
- 1825034
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28