Recall Z-1395-2013— Orthovita, Inc., dBA Stryker Orthobiologics.
Class II · Terminated
Class II FDA medical device recall by Orthovita, Inc., dBA Stryker Orthobiologics., initiated 2012-11-10, terminated 2014-10-29. FDA's recall record names no specific 510(k) clearance for this event. Product: Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 8", Part Number 2110-0525 Product Usage: Facilitate placement of bone cement in weakened or diminished bone. Reason: 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..
- Recalling firm
- Orthovita, Inc., dBA Stryker Orthobiologics.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-11-10
- Terminated
- 2014-10-29
- Firm location
- Malvern, PA, United States
Product description
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 8", Part Number 2110-0525 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.