—#181478

Product

Comprehensive VRS Inserter, shoulder prosthesis, Item No. 110019068. UDI: (01)00880304829503 (10)814100, (01)00880304829503 (10)570640, (01)00880304829503 (10)728890, (01)00880304829503 (10)977300

FDA product code: PHX — Shoulder Prosthesis, Reverse Configuration
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K152754
Affected lot / code info: Lots 814100, 570640, 728890, 977300

Why it was recalled

The product is being recalled due to the central screw drill seizing inside the Comprehensive VRS Inserter, which may lead to an extension of surgery to find a replacement device.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

On May 11, 2020, the firm distributed Urgent Medical Device Recall letters to affected customers. Distributors were asked to return all affected product from their distributorship and from affected hospitals within their territory. Distributors should identify whether there are any additional hospitals that the recalling firm has not notified and provide a list of these additional accounts to Zimmer Biomet. Risk managers at hospitals were asked to take the following actions: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have 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. If the product has been further distributed, provide your customers with the recall notice for hospitals and ensure documentation. 4. Complete the Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form should be returned even if you do not have affected products at your facility. 5. Retain a copy of the acknowledgement form with your recall 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 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 in the states of CA, FL, IN, KS, KY, MI, OH, and TX. Foreign distribution to Netherlands.

Timeline

Recall initiated: 2020-05-11
Terminated: 2020-11-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #181478. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.