Z-1615-2020Class II

Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate With Taper Adapter-indicated for primary...

Name: Z-1615-2020 Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate With Taper Adapter-indicated for primary...
Creator: Biomet, Inc.
Published: 2020-02-25
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2020-02-25 / Terminated / root cause: packaging

FDA source

Biomet, Inc. began a recall of Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate With Taper Adapter-indicated for primary, fracture, or revision total shoulder replacement for... on 2020-02-25. FDA classified it as Class II and gives the reason as "Package is intended to contain one (1) baseplate and one (1) taper adapter; however, devices may be packaged with two (2) baseplates and no (0) adapters". 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-1615-2020
Classification: Class II
Status: Terminated
Initiated: 2020-02-25
Posted: 2020-03-31
Terminated: 2020-08-05
Recalling firm: Zimmer GmbH
Product: Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate With Taper Adapter-indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency Item Number: 010000589
Product code: PHX Shoulder Prosthesis, Reverse Configuration
Reason for recall: Package is intended to contain one (1) baseplate and one (1) taper adapter; however, devices may be packaged with two (2) baseplates and no (0) adapters.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Zimmer Biomet issued notification letter on 2/25/20 via email to the International consignees states reason for recall, health risk and action to take: Hospital Responsibilities 1. Review this notification and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. If the product has been further distributed, provide your customers with the field safety notice for hospitals and ensure documentation. 4. Complete Attachment 1 Certification of Acknowledgement Form and send to [email protected] form must be returned even if you do not have affected products available to return in your facility. 5. Retain a copy of the acknowledgement form with your field action records in the event of a compliance audit of your facilitys documentation. 6. If you have further questions or concerns after reviewing this notice, please contact your Zimmer Biomet representative.
Quantity in commerce: 21 units
Distribution: International distribution - country of Netherland.s
Product codes and lots: Lot Number: 410420 UDI: (01) 0 0880304 53246 5 (17) 290825 (10) 410420

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1615-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1615-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-08	2020-03-31

Product code PHX

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)