GoDirect Screw-Retaining Top Part Numbers: 4500-61
FDA device recall Z-0961-2017 · posted 2017-01-09 · Terminated
Recall details
- Recalling firm
- Implant Direct Sybron Manufacturing, LLC
- Reason for recall
- Consignees received product 6060-62, Replant Overdenture Abutment with the label for 4500-61 GoDirect Screw-Retaining Top.
- Action taken
- On 11/28/16 customers were called and instructed to return the product.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- DZE
- Quantity affected
- 14
- Distribution
- U.S. distribution to the following; WA. Foreign distribution to the following; Netherlands.
- Date initiated
- 2016-11-28
- Date posted
- 2017-01-09
- Date terminated
- 2017-02-16
- Location
- Westlake Village, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPECTRA SYSTEM DENTAL IMPLANTS 2008 (K090234) | Implant Direct, LLC | 2009-05-15 |