CLASS II Device recall · Reported 11 Jul 2018 · FDA Enforcement Report
Replant 5.0mmD Abutment recalled by Implant Direct Sybron
Implant Direct Sybron Manufacturing is recalling Replant 5.0mmD Abutment, distributed in 16 states. The recall was initiated on 18 May 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-2376-2018
- FDA event ID
- 80281
- Recalling firm
- Implant Direct Sybron Manufacturing, Thousand Oaks, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 May 2018
- FDA classified
- 5 Jul 2018
- Reported
- 11 Jul 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Other Medical Devices
Timeline
| 18 May 2018 | Recall initiated by company | |
| 5 Jul 2018 | Classified by FDA | +48 days |
| 11 Jul 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
Due to out of specification, the clinician would not be able to fit and engage the abutment with the implant
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60
Where it was distributed
CA, FL, GA, IL, LA, MI, MT, NC, NJ, NY, OK, OR, SC, SD, TN & WA; International: Jordan, Great Britain, Germany, Spain, Italy & Poland
CaliforniaFloridaGeorgiaIllinoisLouisianaMichiganMontanaNorth CarolinaNew JerseyNew YorkOklahomaOregonSouth CarolinaSouth DakotaTennesseeWashington
Questions about this recall
Why was it recalled?
Due to out of specification, the clinician would not be able to fit and engage the abutment with the implant
Which lots are affected?
Lot numbers: 45353, 66011, and 75850
Where was it sold?
CA, FL, GA, IL, LA, MI, MT, NC, NJ, NY, OK, OR, SC, SD, TN & WA; International: Jordan, Great Britain, Germany, Spain, Italy & Poland
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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