Recalls / —
—#128266
Product
Zimmer Dental Tapered Screw-Vent Implant, Catalog TSVT6B13, Lot 62284006
- FDA product code
- DZE — Implant, Endosseous, Root-Form
- Device class
- Class 2
- Medical specialty
- Dental
- 510(k) numbers
- K101880, K101977
- Affected lot / code info
- Catalog Number TSVT6B13, Lot Number 62284006. 5-year expiration. January 2018.
Why it was recalled
Zimmer Dental is conducting a voluntary recall of a single lot of the Tapered Screw-Vent Implant, Catalog Number TSVT6B13, Lot number 62284006, due to a potential crack in the cap of the outer vial.
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
Recall notification letters sent to customers on 06/25/14. The recall letter, titled "URGENT DEVICE RECALL NOTICE", delivered to customers via a courier, with instructions for returning any unused affected product. The recall letter was accompanied with a response form and provided the following information to customers: product information with codes, reason for recall, risks, responsibilities, MedWatch Reporting and contacting information.
Recalling firm
- Firm
- Zimmer, Inc.
- Address
- 1800 W Center St, Warsaw, Indiana 46580-2304
Distribution
- Distribution pattern
- Nationwide Distribution.
Timeline
- Recall initiated
- 2014-06-25
- Posted by FDA
- 2014-07-14
- Terminated
- 2014-10-30
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #128266. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.