The Recall Desk

Manufacturer

BioHorizons Implant Systems Inc

5 recalls in our database name BioHorizons Implant Systems Inc as the manufacturing or recalling firm.

What the numbers show

Total
5
Critical
0
Severe
0
Most recent
2015-12-16

Of the 5 recalls from BioHorizons Implant Systems Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–5 of 5

  • ModerateFDA (Devices)·Z-0391-2016·2015-12-16

    BioHorizons Dental Implant Recalled Due to Incorrect Length Labeling

    BioHorizons is recalling 32 units of 5.0 x 15mm dental implants because the packaging incorrectly listed the length as 10.5mm.

    Product
    RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx only, Sterile R, BIOHORIZONS(R), Dental Implant
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-1605-2015·2015-05-20

    BioHorizons Recalls Tapered HD Upgrade Set Due to Incorrect Drill Component

    BioHorizons is recalling 48 units of the Tapered HD Upgrade Set because they were packaged with a stainless steel drill instead of the correct titanium component.

    Product
    Tapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only, Product Usage Usage: Surgical instruments used in preparation for dental implant placement
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1058-2014·2014-02-26

    BioHorizons Recalls Dental Implants with Incorrect Length Labeling

    BioHorizons is recalling 119 units of dental implants labeled as 10.5mm but actually measuring 12mm. The recall addresses a labeling error regarding the product's physical dimensions.

    Product
    External Implant RBT, D3 Threadform 4.0 X 10.5mm, REF 40105D3, STERILE R, Rx Only, BioHorizons(R), 2300 Riverchase Center, Birmingham, AL 35244 Usage: dental
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0562-2013·2012-12-26

    BioHorizons Recalls Titanium Tack Starter Kits Due to Cleaning Instructions

    BioHorizons is recalling 1,246 units of Titanium Tack Starter Kits because the provided cleaning instructions may not remove residual contaminants after surgical use.

    Product
    Titanium Tack Starter Kit, REF 400-270, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0561-2013·2012-12-26

    BioHorizons AutoTac Delivery Handle Recalled for Insufficient Cleaning Instructions

    BioHorizons is recalling 174 AutoTac Delivery Handles because cleaning instructions may not remove residual contaminants after surgical use.

    Product
    AutoTac Delivery Handle, REF 400-200, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.
    Category
    Medical Device
    Distribution
    Distributed nationwide