—#208159

Product

RingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer Diameter - Used in hip hemi-arthroplasty Item Number: 11-165206

FDA product code: JDI — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K051569
Affected lot / code info: Lot Number / UDI Number (1) 66540443 (01)00880304001923(17)290408(10)66540443; (2) 66601057 (01)00880304001923(17)290405(10)66601057; (3) 66623486 (01)00880304001923(17)290327(10)66623486; (4) 66635486 (01)00880304001923(17)290327(10)66635486

Why it was recalled

41 mm acetabular outer heads were potentially assembled with a 42 mm locking ring, may lead to joint instability leading requiring surgical intervention

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

Zimmer Biomet issued Urgent Medical Device Recall Letter on 5/17/24 to Distributors and End-Users via FedEx and email. Letter states reason for recall, health risk and action to take: Risk Manager Responsibilities: 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 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 facility s 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. Surgeon Responsibilities: 1. Review this notification for awareness of the contents. 2. There are no specific patient monitoring instructions related to this recall that are recommended beyond your existing follow-up schedule. 3. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facility s documentation. 5. If you have further questions or concerns after reviewing this notice, please call custom

Recalling firm

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

Distribution

Distribution pattern: Worldwide - US Nationwide distribution in the states of AZ, CA, NJ, PA, TX, VA and the country of Chile.

Timeline

Recall initiated: 2024-05-17
Posted by FDA: 2024-06-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #208159. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.