CLASS II Device recall · Reported 8 Feb 2017 · FDA Enforcement Report
SwishTapered Implant recalled by Implant Direct Sybron
Implant Direct Sybron Manufacturing is recalling SwishTapered Implant, distributed in California, Maine, New Mexico, Ohio, Oregon, Texas. The recall was initiated on 12 Dec 2016 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-1112-2017
- FDA event ID
- 76111
- Recalling firm
- Implant Direct Sybron Manufacturing, Westlake Village, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Dec 2016
- FDA classified
- 28 Jan 2017
- Reported
- 8 Feb 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 12 Dec 2016 | Recall initiated by company | |
| 28 Jan 2017 | Classified by FDA | +47 days |
| 8 Feb 2017 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The extender product code (9037-03) that is packaged with the SwishTapered (Part Number 933308; Lot Number 73241) Implant was packaged in the incorrect position. This discrepancy may lead to the possibility of extender not seating properly on the implant, which may lead to micro-leakage and a possible infection to the patient.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
SwishTapered Implant
Where it was distributed
U.S. distribution to the following; NM, TX, CA, OR, OH, ME. Foreign distribution to the following; Netherlands.
Questions about this recall
Why was it recalled?
The extender product code (9037-03) that is packaged with the SwishTapered (Part Number 933308; Lot Number 73241) Implant was packaged in the incorrect position. This discrepancy may lead to the possibility of extender not seating properly on the implant, which may lead to micro-leakage and a possible infection to the patient.
Which lots are affected?
933308 Lot # 73241
Where was it sold?
U.S. distribution to the following; NM, TX, CA, OR, OH, ME. Foreign distribution to the following; 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 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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