Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in U
FDA device recall Z-0364-2020 · posted 2019-11-12 · Terminated
Recall details
- Recalling firm
- Implant Direct Sybron Manufacturing, LLC
- Reason for recall
- A QA inspection confirmed that a Healing Collar (Part number 8735-15) was packaged instead of the Implant ordered.
- Action taken
- Implant Direct Sybron Manufacturing LLC mailed out an urgent medical device recall notice on 8/9/2019 to its customers via FedEx overnight priority instructing them to take the following actions: 1. Please review your inventory for the affected product. If located, please quarantine the affected product and return the product to us according to the instructions on the attached form. 2. Please complete and return the Acknowledgement Form within fortyeight (48) hours, whether you have affected product or not. 3. If you are an authorized Implant Direct Sybron Manufacturing LLC distributor, we request that you identify those customers that may have been shipped the affected product and contact these customers to inform them of this issue within fortyeight (48) hours of receipt. 4.If you have any of the affected product listed above, please return the product and we will send you a replacement part. 5.If you have any questions, please contact Implant Direct Sybron Manufacturing LLC Customer Care at 888-649-6425. Customer Care is available Monday through Friday, between the hours of 5am-5pm PST. 6.If you or your patients have experienced any issues as a result of the affected products noted in this communication, you may voluntarily report the incident to the FDA through the MEDWATCH reporting system at the following: http://www.fda.gov/Safety/MedWatch/HowToReport/ucm053074.htm
- Root cause
- Packaging
- Status
- Terminated
- Product code
- DZE
- Quantity affected
- 23 implants
- Distribution
- U.S.: IN, VA, MD, TX, WA OUS: Japan
- Date initiated
- 2019-08-09
- Date posted
- 2019-11-12
- Date terminated
- 2021-04-27
- 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 |