FDAFDA · Food and drugs·Recall number Z-1322-2020
Abutment Screw Retrieval Instrument 3.0/NP - Product Usage: The instruments for abutment screw retrieval can be used if an abutment screw is broken and a part of the screw is left inside the implant screw channel. If the implant thread needs to be cleaned before placing a new screw, a screw tap repair can be used. The instruments are intended for both simple and advanced treatments.
Published February 26, 2020 · Recall initiated: March 14, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Nobel Biocare Usa Llc
- Distributor
- Worldwide distribution - US Nationwide distribution and countries of CA, AU, JP, BR, ZA, RU, TW, HK, IN, CN, SA, NZ, MO, CO, LB, AT, BE, CH, CY, DE, DK, EE, ES, FI, FR, GB, GG, GR, HR, HU, IE, LT, LU, NL, PL, PT, RS, SE.
- Lot
- (01)07332747084085(10)73585 (01)07332747084085(10)73430 Catalog # 37503
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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