Stryker Orthobiologics Aliquot Plunger Delivery System Recalled for Catheter Breakage
Stryker Orthobiologics is recalling 78 units of the Aliquot Plunger Delivery System because the catheter may break during vertebroplasty procedures.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is attributed to use errors and the correction is limited to a revision of the Directions for Use, fitting the criteria for a moderate severity recall involving procedural risk without reported serious injuries.
Plain-English summary
Stryker Orthobiologics is recalling 78 units of the Aliquot Plunger Delivery System, 4", Part Number 2090-0502. This manual surgical instrument is used to facilitate the placement of bone cement in weakened or diminished bone. The recall is limited to Lot Number Q1006003.
The recall was initiated due to 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 products were distributed nationwide in the United States, specifically in 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. Healthcare providers should review the revised Directions for Use to ensure proper handling of the device.
The recalled product
- Product
- 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
- Manufacturer
- Orthovita, Inc., dBA Stryker Orthobiologics.
- Hazard
- Affected units
- 78
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 2090-0502
- Lot Number Q1006003
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.
See all 13 products in this recall →Related recalls
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