RecallRadar

FDA Device recall Z-1615-2020

Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate With Taper Adapter-indicated for primary, fracture, or revision total shou…

On 2020-04-08 the FDA classified a Class II recall of Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate With Taper Adapter-indicated for primary, fracture, or revision total shou… by Biomet, citing 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.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1615-2020
ClassificationClass II
Statusterminated
Initiated2020-02-25
Published2020-04-08
Last updated2026-09-13 11:55 UTC
CompanyBiomet
Distributionn/a

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

Reason

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.

Identifiers

code_infoLot Number: 410420 UDI: (01) 0 0880304 53246 5 (17) 290825 (10) 410420

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1615-2020%22

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