Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1398-2013 — Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Beveled Needle, 6", Part Number 2110-0524 Product Usage: Facilitate placement of bone cement in weakened or diminished bone

U.S. FDA — Device Enforcement · United States · 2012-11-10 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1398-2013
Date of alert
2012-11-10
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Orthovita, Inc., dBA Stryker Orthobiologics.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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