Z-0642-2019Class II

Zimmer Compress Devices and Instruments: Item Number/Item Description 178350 Compress Device Anti-Rotation...

Name: Z-0642-2019 Zimmer Compress Devices and Instruments: Item Number/Item Description 178350 Compress Device Anti-Rotation...
Creator: Zimmer Biomet, Inc.
Published: 2018-10-12
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2018-10-12 / Terminated / root cause: design

FDA source

Zimmer Biomet, Inc. began a recall of Zimmer Compress Devices and Instruments: Item Number/Item Description 178350 Compress Device Anti-Rotation Spindle 178353 Compress Device Anti-Rotation Spindle... on 2018-10-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0642-2019
Classification: Class II
Status: Terminated
Initiated: 2018-10-12
Posted: 2018-12-19
Terminated: 2020-04-17
Recalling firm: Zimmer GmbH
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 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 code: KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
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.
Root cause tag: design
FDA root cause: 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
Distribution: Nationwide Foreign: CANADA ARGENTINA AUSTRALIA BELGIUM CHILE FINLAND JAPAN NETHERLANDS
Product codes and lots: All

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0642-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0642-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-26	2018-12-19

Product code KWA

K112905Class IICompress(r) Segmental Humeral Replacement SystemBiomet Orthopedics, LLC / cleared 2012-05-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)