Recall Z-2231-2019— Zimmer Biomet, Inc.

Name: FDA recall Z-2231-2019
Creator: U.S. Food and Drug Administration
Published: 2019-07-02

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2019-07-02, terminated 2021-09-10. It names one FDA 510(k) clearance: K142814. Product: Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151810. Reason: Cleaning processes potentially being ineffective.

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-07-02
Terminated: 2021-09-10
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K142814 — Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid TibialBiomet Manufacturing, LLC·cleared 2015-06-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151810

Reason for recall

Cleaning processes potentially being ineffective

Data sourced from openFDA. This site is unofficial and independent of the FDA.