—#165698

Product

ARCOS Modular Revision Hip System, item number 11-300814 orthopedic hip prosthesis femoral stem.

FDA product code: JDI — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K090757
Affected lot / code info: lot 621550 UDI (01)00880304474154(17)280206(10)621550

Why it was recalled

Two lots of the Echo BI-Metric Hip Stem and ARCOS Modular Revision Hip Stem may have been comingled. Potential health consequences include extension of surgery time to find a replacement component.

Root cause (FDA determination)

Process control

Action the firm took

The firm sent an initial email on June 6, 2018, to US distributors that received affected product. Distributors were asked to quarantine any affected product on hand. The formal recall notice was then prepared and emailed to distributors on June 8, 2018. On the same day, hospital risk managers and distributors received notification via courier. " The distributors notice identified the issue and their responsibilities. These responsibilities included locating and removing the product in their territory, as well as identifying hospitals who have previously used the product. " Distributors will return on-hand product to Zimmer Biomet and ensure all of their products are accounted for using the form provided in the letter. " The hospital risk manager notice identified the issue and their responsibilities. These responsibilities include: - Assisting the Zimmer Biomet sales representative with the quarantine of the product - Returning Certificate of Acknowledgement to Zimmer Biomet. If you have further questions or concerns after reviewing this information, please call Zimmer Biomet 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: Zimmer Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

Distribution pattern: US distribution to CA, GA, IL, MO, NY, and VA.

Timeline

Recall initiated: 2018-06-08
Terminated: 2020-04-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #165698. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.