Legacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform, REF: 864213
FDA device recall Z-1041-2020 · posted 2020-02-04 · Terminated
Recall details
- Recalling firm
- Implant Direct Sybron Manufacturing LLC
- Reason for recall
- Some dental implant packages contain incorrect implants, which could lead to surgery rescheduling.
- Action taken
- On 10/07/19, Urgent Medical Device Recall notices were mailed via overnight mail to US customers who were asked to return affected product and to complete and return the acknowledgement form. Consignees in foreign countries were sent Recall notices via overnight mail and/or email on 10/11/2019. Distributors were asked to identify customers that may have received affected product and to inform them of this issue. US Customers with additional questions were encouraged to call Customer Care, Monday through Friday, between 5am-5pm PST, at 1-888-649-6425.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- DZE
- Quantity affected
- 72
- Distribution
- U.S. Nationwide distribution in the states of: KS, LA, OH, RI, CA, NJ, MA, FL, UT, ID, MO, WY, WI, PA, WA. O.U.S. (Foreign): DE, IT, HU, JP
- Date initiated
- 2019-10-07
- Date posted
- 2020-02-04
- Date terminated
- 2021-04-28
- 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 |