CLASS II Device recall · Reported 21 Feb 2018 · FDA Enforcement Report
G7 Dual Mobility Liner F recalled by Zimmer Biomet
Zimmer Biomet is recalling G7 Dual Mobility Liner F, distributed nationwide in the US. The recall was initiated on 25 Aug 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0626-2018
- FDA event ID
- 79104
- Recalling firm
- Zimmer Biomet, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Aug 2017
- FDA classified
- 15 Feb 2018
- Reported
- 21 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 25 Aug 2017 | Recall initiated by company | |
| 15 Feb 2018 | Classified by FDA | +174 days |
| 21 Feb 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide Distribution
Questions about this recall
Why was it recalled?
The affected products are labeled and etched as F-44 mm liners; however, the physical products could potentially be E-42 mm liners.
Which lots are affected?
Item #110024464 Lot# 478340
Where was it sold?
US Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |