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Terminated

Tapered-Screw Vent Implant, HA, 4.7mmD x 8mmL x 4.5mm, Part No. TSVWH8 Dental implant component.

FDA Recall Z-2144-2014 · Posted 2014-08-02

Recalling FirmZimmer, Inc.
Recall StatusTerminated
Product CodeDZE
Date Initiated2014-07-17
Date Terminated2015-02-06
Product Quantity291 units

Reason for Recall

Zimmer Dental is recalling the Tapered Screw-Vent Implant because the inner vial state "03.7 x 8mm" instead of "04.7 x 8 mm."

Firm Action

A recall letter dated 7/22/14 was sent to all customers who purchased the Tapered Screw-Vent Implant to inform them of the recall by Zimmer Dental. The letter informs the customers of the problems identified, risks involved, and the actions to be taken. Customers with questions are instructed to contact Zimmer Dental Customer Service at (800) 854-7019, 7-5pm, Mon-Fri. Customers are instructed to complete the customer response form and e-mail a copy to [email protected] or fax to (574) 372-4265.

Root Cause

Process design

Distribution Pattern

Worldwide Distribution-USA (nationwide) and the countries of Holland, Italy, and Japan.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K013227SCREW VENT IMPLANT; TAPERED SCREW VENT IMPLANTSulzer Dental, Inc. · 2001-11-19K011028SCREW-VENT DENTAL IMPLANT SYSTEMSulzer Dental, Inc. · 2001-05-21

Official Source

View FDA Recall →

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

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