Zimmer Biomet, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0642-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 12, 2018

Date Posted: December 26, 2018

Recall Number: Z-0642-2019

Event ID: 81404

Reason for Recall:

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.

Status: Terminated

Product Quantity: 323 devices US; 208 distributed OUS

Code Information:

All

Distribution Pattern:

Nationwide Foreign: CANADA ARGENTINA AUSTRALIA BELGIUM CHILE FINLAND JAPAN NETHERLANDS

Voluntary or Mandated:

Voluntary: Firm initiated