🔍 RecallPedia

Titanium Tack Starter Kit, REF 400-270, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.

Class I - Dangerous
🏥 Medical Devices Recalled: November 19, 2012 BioHorizons Implant Systems Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot Numbers: K0207015, K0307007, K0407011, K0507007, K0507008, K0507010, K0607003, K0607008, K0607009, K0607017, K0707010, K0707014, K0907001, K0907009, K0907011, K1007006, K1007007, K1007008, K1107009, K1107010, K1107012, K1207002, K0208005, K0208005R, K0308003, 0800120, 0800450, 0800451, 0800674, 0801215, 0801256, 0801728, 0801894, 0802232, 0802528, 0803139, 0900023, 0900884, 0901727, 0902402, 0903145, 0903480, 1000059, 1001465, 1002292, 1004118, 1005055, 1100381, 1100806, 1101066, 1101555, 1102699, 1103390, 1103811, 1104079, 1104778, 1105636, 1200829, 1201978, 1202444, and 1203107
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
BioHorizons Implant Systems Inc
Reason for Recall:
The cleaning instructions provided may not be sufficient to remove residual contaminants after surgical use.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Titanium Tack Starter Kit, REF 400-270, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.

Product Codes/Lot Numbers:

Lot Numbers: K0207015, K0307007, K0407011, K0507007, K0507008, K0507010, K0607003, K0607008, K0607009, K0607017, K0707010, K0707014, K0907001, K0907009, K0907011, K1007006, K1007007, K1007008, K1107009, K1107010, K1107012, K1207002, K0208005, K0208005R, K0308003, 0800120, 0800450, 0800451, 0800674, 0801215, 0801256, 0801728, 0801894, 0802232, 0802528, 0803139, 0900023, 0900884, 0901727, 0902402, 0903145, 0903480, 1000059, 1001465, 1002292, 1004118, 1005055, 1100381, 1100806, 1101066, 1101555, 1102699, 1103390, 1103811, 1104079, 1104778, 1105636, 1200829, 1201978, 1202444, and 1203107

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0562-2013

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