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Terminated

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

FDA Recall Z-1037-2008 · Posted 2008-04-30

Recalling FirmStraumann Usa, Llc
Recall StatusTerminated
Product CodeEGG
Date Initiated2008-01-10
Date Terminated2009-11-06
Product Quantity26 units

Reason for Recall

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.

Firm Action

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.

Root Cause

Mixed-up of materials/components

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K071585P.004 HEALING ABUTMENTS AND CLOSURE SCREWSStraumann USA · 2007-07-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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