Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSV4B10.
FDA device recall Z-1190-2018 · posted 2018-03-05 · Terminated
Recall details
- Recalling firm
- Zimmer Dental Inc
- Reason for recall
- Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be mislabeled.
- Action taken
- On 11/29/2017, customers were notified via letter. Instructions for distributors include to ensure that affected team members are aware of the recall, immediately locate and quarantine affected devices in inventory, notify consignees if product was distributed, make arrangements to immediately return affected devices, and complete and return the Attachment 1 - Inventory Return Certification Form. Instructions for clinicians include to review the recall notice, examine inventory for affected devices, complete and return the Attachment 2 - Certificate of Acknowledgement, and return all affected devices.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- DZE
- Quantity affected
- 995 distribution events total
- Distribution
- Worldwide distribution US nationwide, Canada, Chile, Costa Rica, Denmark, France, Hungary, Italy, Japan, Lebanon, Portugal, Serbia, Spain, and Taiwan.
- Date initiated
- 2017-11-29
- Date posted
- 2018-03-05
- Date terminated
- 2019-02-08
- Location
- Carlsbad, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TAPERED SCREW-VENT IMPLANT, 4.1MM, MODELS: TSV4B8, B10, B11, B13 AND B16, TSV4H8, H11, H13 AND H16 (K072589) | Zimmer Dental, Inc. | 2007-10-04 |