CLASS II Device recall · Reported 12 Nov 2014 · FDA Enforcement Report
Straumann Bone Level Implant RC, SLActive¿, Roxolid¿ recalled
Straumann USA is recalling Straumann Bone Level Implant RC, SLActive¿, Roxolid¿, Loxim Article Number: 021.4308, distributed nationwide in the US. The recall was initiated on 24 Sep 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-0174-2015
- FDA event ID
- 69454
- Recalling firm
- Straumann USA, Andover, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Sep 2014
- FDA classified
- 5 Nov 2014
- Reported
- 12 Nov 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Surgical Instruments
Timeline
| 24 Sep 2014 | Recall initiated by company | |
| 5 Nov 2014 | Classified by FDA | +42 days |
| 12 Nov 2014 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product transfer piece was fitted with a Narrow Connect (NC) instead of a Regular Connect (RC)
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
Straumann Bone Level Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Article Number: 021.4308 Product Usage: Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. Dental implants are for single-stage or two-stage surgery. Dental implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used
Where it was distributed
US Nationwide Distribution
Questions about this recall
Is Straumann Bone Level Implant RC, SLActive¿, Roxolid¿, Loxim Article Number: 021.4308 recalled?
Yes. Straumann USA recalled Straumann Bone Level Implant RC, SLActive¿, Roxolid¿, Loxim Article Number: 021.4308 on 24 Sep 2014. The recall is Class II and its status is Terminated. Recall number Z-0174-2015.
Why was it recalled?
Product transfer piece was fitted with a Narrow Connect (NC) instead of a Regular Connect (RC)
Which lots are affected?
Lot number: GY256
Where was it sold?
US Nationwide Distribution
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.
More recalls from Straumann USA
All 21| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | GM Helix Implant, Endosseous Dental Implant Article No. recalled | Straumann USA | Packaging Defects | Nationwide |
| Device | CLASS II | Straumann Bone Level Tapered (BLT) Implant, D RC, SLActive recalled | Straumann USA | Other | 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 |
| Device | CLASS II | Custom Abutment AS Ti, for Straumann RC, incl recalled | Straumann USA | Packaging Defects | Nationwide |
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