Recall Z-1224-2018— Zimmer Biomet, Inc.

Name: FDA recall Z-1224-2018
Creator: U.S. Food and Drug Administration
Published: 2017-12-12

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2017-12-12, terminated 2019-04-09. It names one FDA 510(k) clearance: K122765. Product: PERSONA¿ THE PERSONALIZED KNEE SYSTEM "PSN TIB STM 5 DEG SZ D R" indicated for patients with severe knee pain and disability due to: - Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.. Reason: A complaint was received for Item 42-5320-067-02, lot 63236047. It was report that there was no set screw or taper plug included in the box. Complaint investigation confirmed that the entire lot of 63236047 was missing the set screw and taper plug..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-12-12
Terminated: 2019-04-09
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K122765 — PERSONA NATURAL TIBIA BASEPLATESZimmer, Inc.·cleared 2012-11-09

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

PERSONA¿ THE PERSONALIZED KNEE SYSTEM "PSN TIB STM 5 DEG SZ D R" indicated for patients with severe knee pain and disability due to: - Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.

Reason for recall

A complaint was received for Item 42-5320-067-02, lot 63236047. It was report that there was no set screw or taper plug included in the box. Complaint investigation confirmed that the entire lot of 63236047 was missing the set screw and taper plug.

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