Recall Z-2187-2012— Zimmer, Inc.

Name: FDA recall Z-2187-2012
Creator: U.S. Food and Drug Administration
Published: 2012-07-13

Class II · Terminated

Class II FDA medical device recall by Zimmer, Inc., initiated 2012-07-13, terminated 2013-09-24. It names one FDA 510(k) clearance: K042695. Product: The NCB Polyaxial Locking Plate System NCB screws 26mm: 02.03155.026, non-sterile Product is implantable screws indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones. These screws are intended for bicortical anchorage.. Reason: Zimmer investigation following a complaint found one lot of NCB Polyaxial Locking Plate System NCB screws, 26mm, distributed in the United States contained incorrect 32 mm screws..

Recalling firm: Zimmer, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-07-13
Terminated: 2013-09-24
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K042695 — NCB PLATING SYSTEMZimmer GmbH·cleared 2004-10-29

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

The NCB Polyaxial Locking Plate System NCB screws 26mm: 02.03155.026, non-sterile Product is implantable screws indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones. These screws are intended for bicortical anchorage.

Reason for recall

Zimmer investigation following a complaint found one lot of NCB Polyaxial Locking Plate System NCB screws, 26mm, distributed in the United States contained incorrect 32 mm screws.

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