The Recall Desk

FDA (Devices) recall action 77911

Zimmer Dental Inc recalled 7 products on 2017-10-04

The FDA (Devices) publishes a recall like this one as 7 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 7 pages.

Products
7
Announced
2017-10-04
Critical
0
Units
14,575

Why these products were recalled

Zimmer Biomet is conducting a medical device field correction for various dental products due to several parts being shipped to the customer with only standard IFUs. All the products were missing supplemental IFUs.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–7 of 7

  • ModerateFDA (Devices)··2017-10-04

    Zimmer Dental Waxing Coping Recall Due to Missing Supplemental Instructions

    Zimmer Biomet is recalling dental waxing copings because they were shipped with only standard instructions, missing required supplemental IFUs.

    Product
    WAXING COPING, CONT 3.5 MM,ANG, REF ZOCWAX3A; WAXING COPING, CONT 3.5 MM, REF ZOCWAX3S; WAXING COPING, CONT 4.5MM, ANG, REF ZOCWAX4A; WAXING COPING, CONT 4.5MM, REF ZOCWAX4S; WAXING COPING, CONT, 5.5MM,ANG, REF ZOCWAX5A; WAXING COPING, CONT, 5.5MM, REF ZOCWAX5S; WAXING…
    Category
    Distribution
    0 states
  • LowFDA (Devices)··2017-10-04

    Zimmer Dental Recalls Impression Caps Due to Missing Supplemental Instructions

    Zimmer Biomet is conducting a field correction for dental impression caps because they were shipped without supplemental instructions for use.

    Product
    IMPRESSION CAP CONT 3.5MM, REF ZOCIMP3A; MPRESSION CAP CONT 3.5MM, REF ZOCIMP3S; IMPRESSION CAP CONT 4.5MM ANG, REF ZOCIMP4A; IMPRESSION CAP CONT 4.5MM, REF ZOCIMP4S; IMPRESSION CAP,CONT,5.5MM, ANG, REF ZOCIMP5A; IMPRESSION CAP, CONT, 5.5MM, REF ZOCIMP5S…
    Category
    Distribution
    0 states
  • LowFDA (Devices)··2017-10-04

    Zimmer Dental Guide Sleeves Recalled for Missing Supplemental Instructions

    Zimmer Biomet is recalling specific dental guide sleeves because they were shipped with only standard instructions, missing required supplemental instructions.

    Product
    Guide Sleeve 3.25 REF 2220, Guide Sleeve 3.75 REF 2221, Guide Sleeve REF 2222, Guide Sleeve REF 2223
    Category
    Distribution
    0 states
  • LowFDA (Devices)··2017-10-04

    Zimmer Dental Recalls Try-In Abutments Due to Missing Supplemental Instructions

    Zimmer Biomet is recalling specific dental try-in abutments because they were shipped with standard instructions but lacked required supplemental instructions.

    Product
    TRY-IN,ABUTMENT, CONT, 3.5X4.5, REF ZOAT34; TRY-IN, ABUTMENT, CONT, 4.5X5.5, REF ZOAT45; TRY-IN, ABUTMENT, CONT, 5.7X6.5, REF ZOAT56; TRY-IN KIT, ABUTMENT, CONT, REF ZOATKIT
    Category
    Distribution
    0 states
  • LowFDA (Devices)··2017-10-04

    Zimmer Dental Recalls Implants Due to Missing Supplemental Instructions

    Zimmer Biomet is recalling 169 dental implants because they were shipped without supplemental instructions for use.

    Product
    IMPLANT,1-PC,ANG,3.0X10MM, REF ZOP30A10; IMPLANT, 1-PC, ANG, 3.0X11.5MM, REF ZOP30A11; IMPLANT, 1 -PC,ANG,3.0X13MM, REF ZOP30A13; IMPLANT 1-PC STR 3.0X10, REF ZOP30S10; IMPLANT, 1-PC,STR,3.0X11.5MM, REF ZOP30S11; IMPLANT,1 -PC,STR,3.0X13MM, REF ZOP30S13
    Category
    Distribution
    0 states
  • LowFDA (Devices)··2017-10-04

    Zimmer Dental Recalls Abutment and Coping Products for Missing Instructions

    Zimmer Biomet is correcting dental abutments and copings because they were shipped with standard instructions but missing supplemental instructions.

    Product
    ABUT GOLD FRICTION-FIT, REF HLA3G; ABUT GOLD FRICTION-FIT, REF HLA4G; COPING GOLD ENG 5.7 MM, REF HLA5G; COPING GOLD NON-ENG. 3.5, REF NEA3G; COPING GOLD NON-ENG. 4.5, REF NEA4G
    Category
    Distribution
    0 states