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U.S. Department of Health and Human Services

Class 2 Device Recall Compress & Mini Compress Devices and Instruments

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  Class 2 Device Recall Compress & Mini Compress Devices and Instruments see related information
Date Initiated by Firm October 12, 2018
Create Date December 19, 2018
Recall Status1 Terminated 3 on April 17, 2020
Recall Number Z-0642-2019
Recall Event ID 81404
510(K)Number K112905  
Product Classification Prosthesis, hip, semi-constrained (metal uncemented acetabular component) - Product Code KWA
Product 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
Mini Taper Spindle, 400 lbs, Extra Small
Mini Taper Spindle, 600 lbs, Extra Small
Mini Taper Spindle, 800 lbs, Extra Small
Short Mini Taper Spindle, 400 lbs, Extra Small
Short Mini Taper Spindle, 600 lbs, Extra Small
Short Mini Taper Spindle, 800 lbs, Extra Small
Code Information All
Recalling Firm/
Zimmer Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact 411 Technical Services
Manufacturer 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.
FDA Determined
Cause 2
Device Design
Action Zimmer notified accounts on 12/13/18 via email and FedEx (both original and expanded accounts) as a follow up to the medical device correction notification dated October 12, 2018. Zimmer Biomet identified additional item numbers that are within the scope of this issue. . Distributors letter identify the issue and their responsibilities, which include: Reviewing the correction notification and ensuring affected team members are aware of the contents. Offering assistance in ensuring users are aware of the updated surgical technique and how to locate it. Destroying previous copies of the surgical technique. Completing the Certification of Acknowledgement. Updated surgical techniques 1110.2-GLBL-en REV0818 and BMET0188.2 REV111218 for the Compress and Mini Compress systems are used, effective immediately, for surgeries that require the affected items. a. Access the full surgical techniques at www.zimmerbiomet.com by navigating to the Limb Salvage specialty and then Bone Compressive Devices under the Medical Professionals menu.
Quantity in Commerce 323 devices US; 208 distributed OUS
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KWA and Original Applicant = BIOMET ORTHOPEDICS LLC.