Z-0626-2018Class II

G7 Dual Mobility Liner 44Mm F

Name: Z-0626-2018 G7 Dual Mobility Liner 44Mm F
Creator: Zimmer Biomet, Inc.
Published: 2017-08-25
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2017-08-25 / Terminated / root cause: labeling and UDI

FDA source

Zimmer Biomet, Inc. began a recall of G7 DUAL MOBILITY LINER 44MM F Product Usage: Intended for use in hip arthroplasty cases which involves the removal of the damaged joint and tissues to be... on 2017-08-25. FDA classified it as Class II and gives the reason as "The affected products are labeled and etched as F-44 mm liners; however, the physical products could potentially be E-42 mm liners". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0626-2018
Classification: Class II
Status: Terminated
Initiated: 2017-08-25
Posted: 2018-02-15
Terminated: 2018-08-16
Recalling firm: Zimmer GmbH
Product: G7 DUAL MOBILITY LINER 44MM F Product Usage: Intended for use in hip arthroplasty cases which involves the removal of the damaged joint and tissues to be replaced with artificial prosthesis. The result of the procedure is to relieve pain and restore a sense of normal function and mobility to the damaged joint.
Product code: KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Reason for recall: The affected products are labeled and etched as F-44 mm liners; however, the physical products could potentially be E-42 mm liners.
Root cause tag: labeling and UDI
FDA root cause: Mixed-up of materials/components
Action: On August 30, 2017 an Urgent medical device recall removal notice was mailed to customers identified as "G7 Dual Mobility Liner". The recall letter requests the following actions to be taken: 1. Review this notification and ensure affected team members are aware of the contents. CF04107 Rev. 2, Eff. Date: 21 Feb. 2017 Ref. CP04102 Recall Activities Page 2 of 4 ZFA 2017-347 2. Immediately locate and quarantine affected product in your inventory. 3. Complete the Certification of Acknowledgement portion of Attachment 1 Inventory Return Certification Form. a. Return a digital copy to corporate [email protected] within three (3) days. 4. Immediately return all affected product from your distributorship and affected hospitals within your territory along with a completed Attachment 1 Inventory Return Certification Form to Zimmer Biomet. Questions or concerns can be directed to Customer Service at 1-574-371-3071
Quantity in commerce: 8
Distribution: US Nationwide Distribution
Product codes and lots: Item #110024464 Lot# 478340

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0626-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0626-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-21	2018-02-15

Product code KWY

K150552Class IIELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc. / cleared 2015-06-04

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)