Recalls / —

—#174678

Product

Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151811

FDA product code

JDI — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K142814

Affected lot / code info

Lot # All lots expiring prior to 06/30/2024 Affected products were distributed between June 2016 and February 2019.

Why it was recalled

Cleaning processes potentially being ineffective

Root cause (FDA determination)

Material/Component Contamination

Action the firm took

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. Complete Certificate of Acknowledgement and send to Corporate Quality. PostMarket@zimmerbiomet.com. This form must be returned even if you do not have affected products at your facility. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 5. 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 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form must be returned. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 5. 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 t

Recalling firm

Firm

Zimmer Biomet, Inc.

Address

56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

Distribution pattern

Distributed to the following states in the USA: AZ, CA, DC, GA, IL, KY, LA, MA, MD, MN, NC, NJ, NM, OH,OK, OR, SC, TX. Distributed to Japan and Netherlands.

Timeline

Recall initiated

2019-07-02

Terminated

2021-09-10

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #174678. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.