Stryker Orthobiologics Aliquot Beveled Needle Recalled for Catheter Breakage
Stryker Orthobiologics is recalling 12 units of the Aliquot Beveled Needle due to reported catheter breakage during vertebroplasty procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with reported instances of component breakage during a surgical procedure, representing a risk-of-harm product where injury has not been explicitly reported in the source text.
Plain-English summary
Orthovita, Inc., dBA Stryker Orthobiologics, is recalling 12 units of the Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument, specifically the Aliquot Beveled Needle, 6" (Part Number 2110-0524). The product is used to facilitate the placement of bone cement in weakened or diminished bone.
The recall was initiated after a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. The breakage was attributed to bending of the catheter during retraction from the needle and was determined to be a use error. The correction for this issue is limited to a revision of the Directions for Use.
The affected units were distributed nationwide in the United States, including the states of AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MD, ME, MI, MO, NC, ND, NH, NJ, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, and WI. The specific lot numbers involved are E909009R.
The recalled product
- Product
- 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
- Manufacturer
- Orthovita, Inc., dBA Stryker Orthobiologics.
- Hazard
- Affected units
- 12
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Manufacturer Part Number 2110-0524
- Lot Number E909009R and E909009R
Distribution
Part of a larger recall action
This product is one of 13 recalled by Orthovita, Inc., dBA Stryker Orthobiologics. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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