CLASS II Device recall · Reported 26 Sep 2018 · FDA Enforcement Report
Gentle Thread PLGA Round Head Interference Screw, 7x20mm recalled
Zimmer Biomet is recalling Gentle Thread PLGA Round Head Interference Screw, 7x20mm, distributed in Indiana, Tennessee. The recall was initiated on 20 Jul 2018 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-3176-2018
- FDA event ID
- 80843
- Recalling firm
- Zimmer Biomet, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Jul 2018
- FDA classified
- 14 Sep 2018
- Reported
- 26 Sep 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 20 Jul 2018 | Recall initiated by company | |
| 14 Sep 2018 | Classified by FDA | +56 days |
| 26 Sep 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The Gentle Thread PLGA Round Head, 7x20mm and the Gentle Thread PLGA Full Thread 10x30 have been commingled.
Product as listed by the FDA
Gentle Thread PLGA Round Head Interference Screw, 7x20mm, Item Number 905612
Where it was distributed
The products were distributed to the following US states: IN, TN. The products were distributed to the following foreign countries: Australia, Chile, Netherlands.
Questions about this recall
Is Gentle Thread PLGA Round Head Interference Screw, 7x20mm recalled?
Yes. Zimmer Biomet recalled Gentle Thread PLGA Round Head Interference Screw, 7x20mm on 20 Jul 2018. The recall is Class II and its status is Terminated. Recall number Z-3176-2018.
Why was it recalled?
The Gentle Thread PLGA Round Head, 7x20mm and the Gentle Thread PLGA Full Thread 10x30 have been commingled.
Which lots are affected?
Lot Number 611330, UDI (1)00880304008526(17)221010(10)611330
Where was it sold?
The products were distributed to the following US states: IN, TN. The products were distributed to the following foreign countries: Australia, Chile, Netherlands.
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 21 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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