Zimmer Dental Tapered Screw-Vent Implant, Catalog TSVT6B13, Lot 62284006
FDA device recall Z-2050-2014 · posted 2014-07-14 · Terminated
Recall details
- Recalling firm
- Zimmer, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- DZE
- Quantity affected
- 129 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2014-06-25
- Date posted
- 2014-07-14
- Date terminated
- 2014-10-30
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TAPERED SCREW-VENT T IMPLANT, TAPERED SCREW-VENT P IMPLANT (K101880) | Zimmer Dental, Inc. | 2010-10-01 |
| TAPERED SCREW-VENT T IMPLANT (K101977) | Zimmer Dental, Inc. | 2010-09-14 |