—#130707

Product

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

FDA product code: DZE — Implant, Endosseous, Root-Form
Device class: Class 2
Medical specialty: Dental
510(k) numbers: K121131
Affected lot / code info: Lot number: GY256

Why it was recalled

Product transfer piece was fitted with a Narrow Connect (NC) instead of a Regular Connect (RC)

Root cause (FDA determination)

Packaging process control

Action the firm took

Straumann USA sent a Field Corrective Action Notice letter dated September 24, 2014 and delivered via United Parcel Service. The letter identified the affected product, problem and actions to be taken. Straumann is requesting the return of unused implants. Returns and Customer Confirmation form is to be returned. Contact firm 781-747- 2514.

Recalling firm

Firm: Straumann USA, LLC
Address: 60 Minuteman Rd, Andover, Massachusetts 01810-1008

Distribution

Distribution pattern: US Nationwide Distribution

Timeline

Recall initiated: 2014-09-24
Posted by FDA: 2014-11-06
Terminated: 2017-06-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #130707. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.