Z-0197-2022 Class II Ongoing
FDA device recall Z-0197-2022 was initiated by Implant Direct Sybron Manufacturing LLC on September 23, 2021 and is designated Class II. Reason for recall: Packaged dental implant contains a different size then the size declared on the labeling. The recall status is ongoing. Affected quantity: 61 implants.
Recall Details
- Product Type
- Devices
- Report Date
- November 10, 2021
- Initiation Date
- September 23, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 61 implants
Product Description
ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform,
Reason for Recall
Packaged dental implant contains a different size then the size declared on the labeling.
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of AZ, CA, HI, IL, KS, LA, MA, MD, MI, MO, MT, NE, NJ, NY, OH, OR, PA, RI, SC, TX, UT, VA, WA, WI and the country of Japan.
Code Information
lot # 166297 / UDI: 10841307101789