FDA Recall Terminated

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

Recall: Z-2300-2020 · Initiated May 11, 2020

Recall

Recall Number: Z-2300-2020
Event Number: 85658
Firm: Biomet, Inc.
FEI Number: 1825034
Product Code: PHX
Status: Terminated
Root Cause: Under Investigation by firm
Initiated: May 11, 2020
Terminated: November 4, 2020
Address: 56 E Bell Dr, Warsaw, IN, 46582-6989

Description

Reason

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.

Action

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 [email protected]. 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 [email protected].

Distribution

US Nationwide Distribution in the states of CA, FL, IN, KS, KY, MI, OH, and TX. Foreign distribution to Netherlands.

Quantity