Recall Z-2131-2014— Zimmer, Inc.

Name: FDA recall Z-2131-2014
Creator: U.S. Food and Drug Administration
Published: 2014-06-10

Class II · Terminated

Class II FDA medical device recall by Zimmer, Inc., initiated 2014-06-10, terminated 2015-01-09. It names one FDA 510(k) clearance: K040593. Product: Zimmer Periarticular Locking Plate System Distal Radial Volar Plate Lateral Column (1st generation stainless steel only). Orthopedic fixation plate. For temporary internal fixation and stabilization of osteotomies and fractures.. Reason: A complaint was received in which it was reported that an 8-hole plate from lot 62276042 had an enlarged hole that is unable to lock the screw, which resulted in the screw head pulling through plate hole..

Recalling firm: Zimmer, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-06-10
Terminated: 2015-01-09
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K040593 — PERIARTICULAR LOCKING PLATES AND SCREWS, 2358, 2359 SERIESZimmer, Inc.·cleared 2004-04-12

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

Zimmer Periarticular Locking Plate System Distal Radial Volar Plate Lateral Column (1st generation stainless steel only). Orthopedic fixation plate. For temporary internal fixation and stabilization of osteotomies and fractures.

Reason for recall

A complaint was received in which it was reported that an 8-hole plate from lot 62276042 had an enlarged hole that is unable to lock the screw, which resulted in the screw head pulling through plate hole.

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