Tapered-Screw Vent Implant, HA, 4.7mmD x 8mmL x 4.5mm, Part… recallZ-2144-2014 · Zimmer, Inc. · initiated Jul 17, 2014
Class II Terminated All recalls posted in August 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Zimmer, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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."
FDA root cause category: Process design
What the company is doing
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.
Recall details
- Recall number
- Z-2144-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jul 17, 2014
- Posted by the FDA
- Aug 2, 2014
- Recalling firm
- Zimmer, Inc.
- Quantity
- 291 units
- Product code
- DZE
- FDA submissions
- K011028, K013227
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Holland, Italy, and Japan.
Product description
Tapered-Screw Vent Implant, HA, 4.7mmD x 8mmL x 4.5mm, Part No. TSVWH8 Dental implant component.
Code information (models, lots, serial numbers)
Lot No. 62552804
Other devices under the same FDA submission
2 devices cleared under K011028, K013227 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Tapered Screw-Vent® TSVWB10ZimVie US Corp LLC · IMPLANT, ENDOSSEOUS, ROOT-FORM805 reports
- Hex-Lock® HLA3/4ZimVie US Corp LLC · IMPLANT, ENDOSSEOUS, ROOT-FORM7 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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