—#183679

Product

Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate with Taper Adapter-Shoulder Prosthesis item: 010000589 - Product Usage: intended to serve as the foundation for the reverse shoulder prosthesis head (glenosphere).

FDA product code: PHX — Shoulder Prosthesis, Reverse Configuration
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K120121, K193373
Affected lot / code info: Lot Numbers: 488150 -UDI (01) 00880304532465 (17) 300623 (10) 488150; and 564110- UDI (01) 00880304532465 (17) 300609 (10) 564110

Why it was recalled

Product potentially being packaged without a taper adapter or baseplate. The package should contain one (1) baseplate and one (1) taper adapter, product may be packaged with two (2) baseplates and no (0) adapters or with no (0) baseplates and two (2) adapters

Root cause (FDA determination)

Packaging process control

Action the firm took

Zimmer Biomet issued Urgent Medical Device Recall Letter dated 9/02/20 to Distributors via email and Hospital Risk Mangers via courier stating reason for recall, health risk and action to take: 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 CorporateQuality.PostMarket@zimmerbiomet.com. 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 CorporateQuality.PostMarket@zimmerbiomet.com.

Recalling firm

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

Distribution

Distribution pattern: US Nationwide distribution including in the states of CO, MN, OH, WY.

Timeline

Recall initiated: 2020-09-02
Terminated: 2020-12-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #183679. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.