Z-1208-2015Class II

Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adaptor, Part Number: 010000589...

Name: Z-1208-2015 Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adaptor, Part Number: 010000589...
Creator: Biomet, Inc.
Published: 2015-01-07
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2015-01-07 / Terminated / root cause: manufacturing process

FDA source

Biomet, Inc. began a recall of Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adaptor, Part Number: 010000589 Lot: 527400 on 2015-01-07. FDA classified it as Class II and gives the reason as "The taper adaptor is missing from the packaging, which may result in a delay in surgery greater than 30 minutes". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1208-2015
Classification: Class II
Status: Terminated
Initiated: 2015-01-07
Posted: 2015-02-24
Terminated: 2015-10-22
Recalling firm: Zimmer GmbH
Product: Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adaptor, Part Number: 010000589 Lot: 527400
Product code: KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Reason for recall: The taper adaptor is missing from the packaging, which may result in a delay in surgery greater than 30 minutes.
Root cause tag: manufacturing process
FDA 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 in commerce: 11- 6 consumed, 5 with distributors
Distribution: Domestic: AL, FL, NY, TX Foreign: None
Product codes and lots: Part Number: 010000589 Lot: 527400

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1208-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1208-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-04	2015-02-24

Product code KWS

K120121Class IIComprehensive Reverse Shoulder-Mini BaseplateBiomet, Inc. / cleared 2012-02-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)