Recall Z-0654-2016— Zimmer Biomet, Inc.

Name: FDA recall Z-0654-2016
Creator: U.S. Food and Drug Administration
Published: 2015-12-09

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2015-12-09, terminated 2016-11-08. It names one FDA 510(k) clearance: K060710. Product: Zimmer Universal Locking System 3.5mm Locking Reconstruction Plate Straight 11 Holes 144mm Length Zimmer Universal Locking System 3.5mm Locking Dual Compression Plate 8 Holes 105mm Length. Indicated for temporary internal fixation and stabilization of osteotomies and fractures.. Reason: The product on the package label did not match what was inside the package. The label was for part number 00-4936-011-13 lot number 62968956 while the product inside the package was part number 00-4936-008-07 lot number 62968974..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-12-09
Terminated: 2016-11-08
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K060710 — UNIVERSAL LOCKING SYSTEM, 3.5MM PLATES AND SCREWS-4936 PLATES,4835 SCREWSZimmer, Inc.·cleared 2006-04-26

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 Universal Locking System 3.5mm Locking Reconstruction Plate Straight 11 Holes 144mm Length Zimmer Universal Locking System 3.5mm Locking Dual Compression Plate 8 Holes 105mm Length. Indicated for temporary internal fixation and stabilization of osteotomies and fractures.

Reason for recall

The product on the package label did not match what was inside the package. The label was for part number 00-4936-011-13 lot number 62968956 while the product inside the package was part number 00-4936-008-07 lot number 62968974.

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