—#67277

Product

Straumann NC Closure Screw, Titanium, Precision attachment, Article Number: 024.2105.04, Straumann, Andover, MA 01810

FDA product code: EGG — Attachment, Precision, All
Device class: Class 1
Medical specialty: Dental
510(k) numbers: K071585
Affected lot / code info: Lot Number: G8677

Why it was recalled

Mislabeled package: Narrow Connection (NC) Closure Screws contain closure screws for the regular connection (RC) bone level implant. The RC closures screw is larger (3.5mm diameter) and therefore, will not fit into the NC implant (3.0mm diameter) narrow connection.

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

Consignees were notified by telephone on 1/10/08 followed by an Urgent Device Recall letter on January 10, 2008. The letter instructs users to return any affected product to the firm along with a recall acknowledgement form. For additional information, contact 978-747-2514.

Recalling firm

Firm: Straumann Usa, Llc
Address: 60 Minuteman Rd, Andover, Massachusetts 01810-1008

Distribution

Distribution pattern: Nationwide Distribution including states of CA, DE, FL, IL, ME, NY, OH, OR, and TX.

Timeline

Recall initiated: 2008-01-10
Posted by FDA: 2008-04-30
Terminated: 2009-11-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #67277. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.