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Terminated

S1813OB 1.8X13mm Sendax MDI Mini Dental Implant O-Ball Prosthetic Head

FDA Recall Z-1703-2010 · Posted 2010-05-27

Recalling Firm3m Imtec Corporation
Recall StatusTerminated
Product CodeDZE
Date Initiated2010-05-14
Date Terminated2010-07-14
Product Quantity189 Implants

Reason for Recall

Product has Incorrect size Labeling. Actual length is 13mm. One label is correct, and one states 10mm.

Firm Action

IMTEC notified consignees by phone on May 14, 2010 and by Certified Letter dated May 14, 2010.

Root Cause

Packaging process control

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K031106IMTEC SENDAX MDI AND MDI PLUS ENDOSSEOUS IMPLANT, MODELS OB-XX, SH-XX, MOB-22, MSH-XXImtec Corp. · 2003-08-12

Official Source

View FDA Recall →

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

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