Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 4", Part Number 2090-0502 Product Usage: Facilitate placement of bone cement in weakened or diminished bone

Class I - Dangerous

🏥 Medical Devices Recalled: November 10, 2012 Orthovita, Inc. Surgical Instruments Nationwide

What Should You Do?

Check if you have this product:
Manufacturer Part Number 2090-0502, Lot Number Q1006003
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
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:: There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 4", Part Number 2090-0502 Product Usage: Facilitate placement of bone cement in weakened or diminished bone

Product Codes/Lot Numbers:

Manufacturer Part Number 2090-0502, Lot Number Q1006003

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1387-2013

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