Recall Z-1807-2018— Zimmer Biomet, Inc.

Name: FDA recall Z-1807-2018
Creator: U.S. Food and Drug Administration
Published: 2017-08-07

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2017-08-07, terminated 2018-08-23. It names 2 FDA 510(k) clearances: K122765, K113369. Product: Persona Cemented Tibial SZ PLT Size H Left, Item Number 42539908301 For use during orthopaedic surgery for implantation of a prosthesis.. Reason: There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetrate the surface of the instrument as a result of the raw material issue..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-08-07
Terminated: 2018-08-23
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

2 on FDA's record

K122765 — PERSONA NATURAL TIBIA BASEPLATESZimmer, Inc.·cleared 2012-11-09
K113369 — ZIMMER PERSONA KNEE SYSTEMZimmer, Inc.·cleared 2012-03-27

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 Cemented Tibial SZ PLT Size H Left, Item Number 42539908301 For use during orthopaedic surgery for implantation of a prosthesis.

Reason for recall

There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetrate the surface of the instrument as a result of the raw material issue.

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