🔍 RecallPedia

OsteoSelect DBM Putty Product Usage: Orthopedic bone filler

Class I - Dangerous
🏥 Medical Devices Recalled: February 21, 2013 Bacterin International Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    B100164 and B110115
  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:
Bacterin International, Inc.
Reason for Recall:
The firm's retesting procedure was not validated.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

OsteoSelect DBM Putty Product Usage: Orthopedic bone filler

Product Codes/Lot Numbers:

B100164 and B110115

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1138-2013

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Instrument Kit for use with OsteoSponge SC grafts. The Instrument Kit is used to insert OsteoSponge SC grafts to fill bone defects in the subchondral region of articulating joints. The Instrument Kit is used to establish and maintain a port of entry for arthroscopic instruments or for an open procedure. The kit is also used to insert the OsteoSponge¿ SC graft during surgery. Such procedures include, but are not limited to, subchondral bone repair. Affected Part numbers are 6508 and 6511.

Bacterin International

Class I - Dangerous

Instrument Kits for OsteoSponge SC grafts, OsteoLock Facet Stabilization Dowel, and BacFast HD Facet Dowel have incorrect sterilization parameters in the IFU and on the lid of the kits. Sterilization parameters for the Steam Gravity 121 degree C (250 F) cycle were not validated and the dry time for the Steam Pre-Vacuum 132 degree C (270 F) cycle was omitted.

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Wound Drain - Label reads in part "Elutia ***Hubless Coated Silicone Surgical Wound Drain***" Two different sizes, 10 units per box: 19 Fr Round Hubless part number 7110; 24 Fr Round Hubless part number 7118. AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system.

Bacterin International

Class I - Dangerous

The recalling firm reported there was inadvertent omission of quarterly (Q4 - 2013 and Q1 - 2014) dose audits/verifications on the affected products. All of the affected products were appropriately sterilized

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