Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only, Sterile R Dental Implant
Reported: November 20, 2019 Initiated: October 26, 2018 #Z-0363-2020
Product Description
Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only, Sterile R Dental Implant
Reason for Recall
packaging error; An internal QA inspection revealed that a incorrect healing collar could have been packaged in an implant assembly kit.
Details
- Recalling Firm
- Implant Direct Sybron Manufacturing, LLC
- Units Affected
- 53 implants
- Distribution
- US distribution in the states of: CA, UT, VA, NY, IL, AR, TX, OH, NV, FL, ID, AK, NC, KS, MN, AZ, CO,
- Location
- Westlake Village, CA
Frequently Asked Questions
What product was recalled? ▼
Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only, Sterile R Dental Implant. Recalled by Implant Direct Sybron Manufacturing, LLC. Units affected: 53 implants.
Why was this product recalled? ▼
packaging error; An internal QA inspection revealed that a incorrect healing collar could have been packaged in an implant assembly kit.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 20, 2019. Severity: Moderate. Recall number: Z-0363-2020.
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