CLASS II Device recall · Reported 31 May 2017 · FDA Enforcement Report
Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD recalled
Implant Direct Sybron Manufacturing is recalling Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD, distributed nationwide in the US. The recall was initiated on 2 May 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-2125-2017
- FDA event ID
- 77171
- Recalling firm
- Implant Direct Sybron Manufacturing, Westlake Village, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 May 2017
- FDA classified
- 22 May 2017
- Reported
- 31 May 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 2 May 2017 | Recall initiated by company | |
| 22 May 2017 | Classified by FDA | +20 days |
| 31 May 2017 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Implant Direct Sybron Manufacturing is recalling the Legacy Full-Contour Abutment 3.5mmD Assembly because it may be out of Implant Direct specification.
Product as listed by the FDA
Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD
Where it was distributed
Worldwide Distribution - Nationwide Distribution and to the countries of : European Union (HU, GB, DE, DK, IT, HR, FR), and Japan
Questions about this recall
Why was it recalled?
Implant Direct Sybron Manufacturing is recalling the Legacy Full-Contour Abutment 3.5mmD Assembly because it may be out of Implant Direct specification.
Which lots are affected?
89103, 83493, 78986
Where was it sold?
Worldwide Distribution - Nationwide Distribution and to the countries of : European Union (HU, GB, DE, DK, IT, HR, FR), and Japan
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.
More recalls from Implant Direct Sybron Manufacturing
All 33| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | The Drill Stop Kit recalled by Implant Direct Sybron | Implant Direct Sybron Manufacturing | Other | Nationwide |
| Device | CLASS II | Legacy Smartbase, Ne 3.0d 1mml recalled by Implant Direct Sybron | Implant Direct Sybron Manufacturing | Other | Nationwide |
| Device | CLASS II | ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD recalled | Implant Direct Sybron Manufacturing | Packaging Defects | Nationwide |
| Device | CLASS II | ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD recalled | Implant Direct Sybron Manufacturing | Packaging Defects | Nationwide |
| Device | CLASS II | SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform recalled | Implant Direct Sybron Manufacturing | Device Malfunction | CA |
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