Z-0972-2019Class II

Comprehensive Reverse Shoulder System Glenosphere Mini Baseplate with Taper Adapter, Model Number 010000589...

Name: Z-0972-2019 Comprehensive Reverse Shoulder System Glenosphere Mini Baseplate with Taper Adapter, Model Number 010000589...
Creator: Zimmer Biomet, Inc.
Published: 2018-12-21
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2018-12-21 / Terminated / root cause: packaging

FDA source

Zimmer Biomet, Inc. began a recall of Comprehensive Reverse Shoulder System Glenosphere Mini Baseplate with Taper Adapter, Model Number 010000589 Biomet Comprehensive Reverse Shoulder products are... on 2018-12-21. FDA classified it as Class II and gives the reason as "The product was potentially being packaged without a taper adapter". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0972-2019
Classification: Class II
Status: Terminated
Initiated: 2018-12-21
Posted: 2019-03-01
Terminated: 2020-05-06
Recalling firm: Zimmer GmbH
Product: Comprehensive Reverse Shoulder System Glenosphere Mini Baseplate with Taper Adapter, Model Number 010000589 Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff.
Product code: KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Reason for recall: The product was potentially being packaged without a taper adapter.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: The firm, Zimmer Biomet, sent an "URGENT MEDICAL DEVICE RECALL" letters dated 12/21/18 to customers. The letters described the product, problem and actions to be taken. The customers were instructed to do the following: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have unconsumed affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete Attachment 1 Certificate of Acknowledgement and send to [email protected]. This form must be returned even if you do not have affected products at your facility. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 5. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to [email protected].
Quantity in commerce: 52
Distribution: US Distribution to states of:: AR, KY, and WA.; Internationally to: Australia and Japan.
Product codes and lots: Lot Numbers 994110, 921950 UDI Numbers: (01) 0 0880304 53246 5 (17) 280920 (10) 994110 (01) 0 0880304 53246 5 (17) 280913 (10) 921950

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0972-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0972-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-13	2019-03-01

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)