—#184835

Product

Vanguard 360 Revision System Posterior Augment With Bolt - Product Usage: intended for use in knee arthroplasty Item Number: 185422

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K093293
Affected lot / code info: Lot Number: 098780 UDI Number: (01) 00880304482739 (17) 290501 (10) 098780

Why it was recalled

Incorrect bolt -tibial bolts in package instead of femoral bolts may delay procedure

Root cause (FDA determination)

Process control

Action the firm took

.Zimmer Biomet issued Urgent Medical Device Recall letter issued on 12/1/20 to distributors with direct sales and/or fielded inventory via email and traceable letter sent via FedEx. Hospitals with direct sales or current inventory will be notified via FedEx. Letter states reason for recall , health risk and action to take: Distributors esponsibilities include: locating and removing the product in their territory, as well as identifying hospitals who have previously used the product. 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 field safety notice for hospitals and ensure documentation. 4. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form shall 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: Worldwide distribution - US Nationwide distribution in the state of FL and the countries of Korea, Japan, Netherlands.

Timeline

Recall initiated: 2020-12-01
Terminated: 2022-07-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #184835. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.