🔍 RecallPedia

Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous procedures to facilitate placement of bone cement in weakened or diminished bone

Class I - Dangerous
🏥 Medical Devices Recalled: August 20, 2015 Orthovita, Inc. Surgical Instruments Nationwide

What Should You Do?

  1. Check if you have this product:
    All lots, Model Number of device: 2090-0501, 2090-0502, 2090-0504, 2090-0505
  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:
Orthovita, Inc., dBA Stryker Orthobiologics.
Reason for Recall:
Two isolated instances of holes in the outer header bag component of the double barrier sterile packaging configuration
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous procedures to facilitate placement of bone cement in weakened or diminished bone

Product Codes/Lot Numbers:

All lots, Model Number of device: 2090-0501, 2090-0502, 2090-0504, 2090-0505

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2772-2015

Related Recalls

Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle- Model Numbers: 2110-0505 Beveled Needle, 11 gauge x 4 inch 2110-0524 Beveled Needle, 11 gauge x 6 inch 2110-0506 Diamond Needle, 11 gauge x 4 inch 2110-0529 Diamond Needle, 11 gauge x 6 inch Intended Use: Can be used in either direct (or open) and percutaneous (or deep) delivery of bone cement.

Orthovita, Inc.

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There is the potential for a breach in the inner or outer packaging pouches of all lots of the Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle.

Dec 4, 2014 Surgical Instruments Nationwide View Details →

Stryker Orthobiologics Imbibe Bone Marrow Aspiration Needle, Model Numbers: 2090-0027 Needle (bullet-tip), 11 gauge x 4 inch 2090-0028 Needle (bullet-tip), 11 gauge x 6 inch 2090-0029 Needle (bullet-tip), 8 gauge x 6 inch 2090-0047 Needle (bullet-tip), 8 gauge x 8 inch 2090-0030 Needle (bullet-tip), Fenestrated, 8 gauge x 6 inch intended for use to aspirate bone marrow or autologous blood.

Orthovita, Inc.

Class I - Dangerous

There is the potential for a breach in the inner or outer packaging pouches of all lots of the Imbibe Bone Marrow Aspiration Needle.

Dec 4, 2014 Surgical Instruments Nationwide View Details →