—#203964

Product

Compress Device Segmental Anchor Plug, 20 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178410

FDA product code: KWA — Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Device class: Class 3
Medical specialty: Orthopedic
510(k) numbers: K062998
Affected lot / code info: Lot Numbers/UDI 332070 (01)00880304259782(17)270812(10)332070; 608620 (01)00880304259782(17)271113(10)608620; 671750 (01)00880304259782(17)271115(10)671750; 752800 (01)00880304259782(17)270816(10)752800; 856930 (01)00880304259782(17)271030(10)856930; 856930R (01)00880304259782(17)271030(10)856930R; 930690 (01)00880304259782(17)270630(10)930690;

Why it was recalled

Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery

Root cause (FDA determination)

Device Design

Action the firm took

Zimmer Biomet issued Urgent Medical Device Recall letter on 10/09/23 to Distributors and Risk Managers via email/courier . Letter states 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 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 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

Recalling firm

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

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, CANADA, CHILE, JAPAN, NETHERLANDS, NEW ZEALAND.

Timeline

Recall initiated: 2023-10-09
Posted by FDA: 2023-11-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #203964. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.