CLASS II Device recall · Reported 21 Jan 2015 · FDA Enforcement Report
Drill set long, drill stop compatible for diameter implant recalled
Straumann USA is recalling Drill set long, drill stop compatible for diameter implant, Article Number 040.447S, distributed nationwide in the US. The recall was initiated on 27 Oct 2014 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-0981-2015
- FDA event ID
- 69767
- Recalling firm
- Straumann USA, Andover, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Oct 2014
- FDA classified
- 15 Jan 2015
- Reported
- 21 Jan 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Dental Devices
Timeline
| 27 Oct 2014 | Recall initiated by company | |
| 15 Jan 2015 | Classified by FDA | +80 days |
| 21 Jan 2015 | 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
Drill set may contain incorrect drill.
Product as listed by the FDA
Drill set long, drill stop compatible for 4.8mm diameter implant, Article Number 040.447S Endosseous dental implant drill set.
Where it was distributed
Nationwide in the following states: AZ, CA, CO,CT, FL, IA, IL, IN, LA, MA, MD, ME, MN, MO, NC, NJ, NY, OH, OK, OR, PA, RI, TX, VA and WV. Worldwide in the following countries by Institut Straumann AG distribution network: Austria, Australia, Canada, Germany, Spain, Finland, France, United Kingdom, Netherlands, Belgium, Switzerland, Ireland, Italy.
Nationwide ArizonaCaliforniaColoradoConnecticutFloridaIowaIllinoisIndianaLouisianaMassachusettsMarylandMaineMinnesotaMissouriNorth CarolinaNew JerseyNew YorkOhioOklahomaOregon
Questions about this recall
Why was it recalled?
Drill set may contain incorrect drill.
Which lots are affected?
Lot Numbers: GY037, HA443, HE874, HL216
Where was it sold?
Nationwide in the following states: AZ, CA, CO,CT, FL, IA, IL, IN, LA, MA, MD, ME, MN, MO, NC, NJ, NY, OH, OK, OR, PA, RI, TX, VA and WV. Worldwide in the following countries by Institut Straumann AG distribution network: Austria, Australia, Canada, Germany, Spain, Finland, France, United Kingdom, Netherlands, Belgium, Switzerland, Ireland, Italy.
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 Straumann USA
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|---|---|---|---|---|---|
| Device | CLASS II | GM Helix Implant recalled by Straumann USA | Straumann USA | Packaging Defects | Nationwide |
| Device | CLASS II | GM Helix Implant, Endosseous Dental Implant Article No. recalled | Straumann USA | Packaging Defects | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS II | Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm recalled | Henry Schein | Packaging Defects | Nationwide |
| Device | CLASS II | GM Helix Implant, Endosseous Dental Implant Article No. recalled | Straumann USA | Packaging Defects | Nationwide |
| Device | CLASS II | KL Owen Custom Orthodontic Solution recalled by Klowen Braces | Klowen Braces | Device Malfunction | Nationwide |
| Device | CLASS II | Straumann n!ce PMMA Full-arch Restoration recalled | Straumann USA | Other | 8 states |
| Device | CLASS II | Straumann n!ce Zr, HT, Full-arch Restoration recalled | Straumann USA | Other | 8 states |