—#128883

Product

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

FDA product code: DZE — Implant, Endosseous, Root-Form
Device class: Class 2
Medical specialty: Dental
510(k) numbers: K011028, K013227
Affected lot / code info: Lot No. 62552804

Why it was recalled

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."

Root cause (FDA determination)

Process design

Action the firm took

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 corporatequality.postmarket@zimmer.com or fax to (574) 372-4265.

Recalling firm

Firm: Zimmer, Inc.
Address: 1800 W Center St, Warsaw, Indiana 46580-2304

Distribution

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

Timeline

Recall initiated: 2014-07-17
Posted by FDA: 2014-08-02
Terminated: 2015-02-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #128883. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.