CLASS II Device recall · Reported 29 Oct 2014 · FDA Enforcement Report

Straumann Bone Level Tapered Implant RC, SLActive¿ recalled

Straumann USA is recalling Straumann Bone Level Tapered Implant RC, SLActive¿, Roxolid¿, Loxim Article Number: 021, distributed in Florida, Massachusetts. The recall was initiated on 19 Sep 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot number: GY030 Exp. 2019-04

Quantity recalled6 units

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-0117-2015
FDA event ID: 69379
Recalling firm: Straumann USA, Andover, MA
Classification: Class II
Status: Terminated
Recall initiated: 19 Sep 2014
FDA classified: 23 Oct 2014
Reported: 29 Oct 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

19 Sep 2014	Recall initiated by company
23 Oct 2014	Classified by FDA	+34 days
29 Oct 2014	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

Assembled with Narrow Connect (NC) transfer piece instead of Regular Connect (RC)

Product as listed by the FDA

Straumann Bone Level Tapered Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Article Number: 021 .5308 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.

Where it was distributed

US Distribution in states of: FL and MA.

Florida Massachusetts

Questions about this recall

Why was it recalled?

Assembled with Narrow Connect (NC) transfer piece instead of Regular Connect (RC)

Which lots are affected?

Lot number: GY030 Exp. 2019-04

Where was it sold?

US Distribution in states of: FL and MA.

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

All 22

Reported	Class	Recall	Company	Reason	Where
23 Sep 2026Device	CLASS II	GM Helix Implant recalled by Straumann USA	Straumann USA	Packaging Defects	Nationwide
19 Aug 2026Device	CLASS II	GM Helix Implant, Endosseous Dental Implant Article No. recalled	Straumann USA	Packaging Defects	Nationwide
19 Aug 2026Device	CLASS II	Straumann Bone Level Tapered (BLT) Implant, D RC, SLActive recalled	Straumann USA	Other	Nationwide
6 May 2026Device	CLASS II	Straumann n!ce PMMA Full-arch Restoration recalled	Straumann USA	Other	8 states
6 May 2026Device	CLASS II	Straumann n!ce Zr, HT, Full-arch Restoration recalled	Straumann USA	Other	8 states

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