Recall Z-2575-2017— Zimmer Biomet, Inc.

Name: FDA recall Z-2575-2017
Creator: U.S. Food and Drug Administration
Published: 2017-02-28

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2017-02-28, terminated 2018-02-27. It names one FDA 510(k) clearance: K070978. Product: Segmental fluted stem, 19x250mm bwd, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants. Reason: Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-02-28
Terminated: 2018-02-27
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K070978 — ZIMMER SEGMENTAL SYSTEMZimmer, Inc.·cleared 2007-07-03

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

Segmental fluted stem, 19x250mm bwd, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants

Reason for recall

Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.

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