FDA Enforcement Class II Terminated

Zimmer Compress Devices and Instruments: Item Number/Item Description 178350 Compress Device Anti-Rotation Spindle 178353 Compress Device Anti-Rotation Spindle 178356 Compress Device Anti-Rotation Spindle 178359 Compress Device Anti-Rotation Elliptical Spindle 178537 Compress Device Centering Sleeve 15mm 178541 Compress Device Centering Sleeve 19mm 178545 Compress Device Centering Sleeve 23mm 178544 Compress Device Centering Sleeve 22mm 178738 Compress Device Centering Sleeve 28mm 178542 Compress Device Centering Sleeve 20mm 32-481123 Compress Instrument Drill For Anti-Rotation Pin 178757 Mini Taper Spindle, 400 lbs, Extra Small 178758 Mini Taper Spindle, 600 lbs, Extra Small 178759 Mini Taper Spindle, 800 lbs, Extra Small 178787 Short Mini Taper Spindle, 400 lbs, Extra Small 178788 Short Mini Taper Spindle, 600 lbs, Extra Small 178789 Short Mini Taper Spindle, 800 lbs, Extra Small

Recall: Z-0642-2019 · Reported December 26, 2018

Enforcement

Recall Number: Z-0642-2019
Event ID: 81404
Classification: Class II
Status: Terminated
Product Type: Devices
Firm: Zimmer Biomet, Inc.
Voluntary / Mandated: Voluntary: Firm initiated
Initial Notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Report Date: December 26, 2018
Initiation Date: October 12, 2018
Classification Date: December 19, 2018
Termination Date: April 17, 2020
Address: 56 E Bell Dr, Warsaw, IN, 46582-6989, United States

Description

Reason

Correction to update the surgical technique for the Compress System. To make users aware of the changes that were made only to the selection criteria section on page 42 regarding which array to use in the placement of the anti-rotation pins.

Code Info

All

Distribution

Nationwide Foreign: CANADA ARGENTINA AUSTRALIA BELGIUM CHILE FINLAND JAPAN NETHERLANDS

Quantity

323 devices US; 208 distributed OUS