—#180165

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

FDA product code: PHX — Shoulder Prosthesis, Reverse Configuration
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K120121
Affected lot / code info: Lot Number: 410420 UDI: (01) 0 0880304 53246 5 (17) 290825 (10) 410420

Why it was recalled

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 (FDA determination)

Packaging process control

Action the firm took

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 fieldaction.emea@zimmerbiomet.com.This 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.

Recalling firm

Firm: Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

Distribution pattern: International distribution - country of Netherland.s

Timeline

Recall initiated: 2020-02-25
Terminated: 2020-08-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #180165. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.